Blood Bank Of San Bernardino and Riverside Counties
Blood product, which was labeled as leukoreduced, but was not tested to verify white blood cell count, was distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood products, which did not meet the minimum requirement for volume, were distributed.
Blood Bank of San Bernardino and Riverside Counties
Blood product, collected in a manner that may have compromised the sterility of the unit, was distributed.
Blood product, for which the entire amount of additive solution was not added during manufacturing, was distributed.
Blood products, which may have been exposed to unacceptable storage temperatures, were distributed.
The American National Red Cross South Carolina Region
Blood product, which contained an insufficient plasma volume, was distributed.
Blood products, collected from a donor who was taking the medication Avodart, were distributed.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Blood products, for which there was a discrepancy in the sample tubes for viral marker testing, were distributed.
Blood product, which may have reached an unacceptable temperature during storage, was distributed.
Worldwide Distribution - US (Nationwide) to states of: MN, GA, and CA; and International to: England.
The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data program application (software), which is supplied for installation in existing mainframe or decentralized computers or a computer network. This software system will not be the software directly used to run, steer, or control any specific laboratory analyzer or equipment. It is intended for use in laboratory facilities, including a central laboratory or in a multiple laboratory environment servicing satellite laboratories, reference laboratories, clinics, etc. Centricity Laboratory System is not intended for direct patient contact.   The Centricity Laboratory System product is designed to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. It integrates with other Hospital Information Systems (HIS) through HL7 interface by order entering and also report processing. The Centricity Laboratory System is intended to interface with various lab results. Centricity Laboratory System is intended to be used by laboratory technologists, technicians, analyst and other trained/site authorized system users
GE Healthcare is aware of a potential safety issue associated with the use of GE Centricity Laboratory Core Lab calculated results in two scenarios.    In Scenario 1: Calculated results greater than 6 digits plus a decimal are reported as 0 instead of TOO BIG when significant figures are not defined for the item.     In Scenario 2: Calculated results greater than 6 digits plus a decimal are truncated if significant figures are defined.
University of Miami Miller School of Medicine Tissue Bank
Nationwide, including Puerto Rico  and St. Thomas, Virgin Island.  Coutries: South Korea, Venezuela, Canada, Netherland, Jamaica, El Salvador, Colombia, Switzerland, Dominican Republic, Greece, Australia, Trinidad, W.I. Saudi Arabia, San Jose, and Guam.
Human tissue allografts, whose donor eligibilities were not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed.
HCG (Lyophilized) Stock # 21714, 5000 IUnits-5 mL vial, Compounded by NuVision Pharmacy Dallas, TX 75244
Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.
Sermorelin/GHRP-6, 3 mg/3 mg, 5 mL vial, Stock # 21740, Compounded by NuVision Pharmacy, Dallas, TX 75244
Worldwide Distribution - US (Nationwide) and the countries of: Australia, Austria, Belgium, Brazil, Switzerland, Czech Republic, Germany, Spain, Finland, France, Great Britain, Israel, Italy ,Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sweden, Solvenia, Solvakia, Turkey, South Africa, and UK.
Codman Certas Programmable Valve In Line Valve Only Product Code: 82-8800     Product Usage:  The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting.
Lot Codes:  CLNCB1  CMBBP1  CMBCPN  CMCBWG  CMCC2V  CMDCN8  CMDDJN  CMGB8H  CMJCL8  CMJCPW  CMKB21  CMMCGR  CMNBFB  CMNBZJ  CMNC8T  CMNCYL  CMPB4V  CNCCPF  CNDBCW  CNDBRH  CNDCJ2  CNFCK7  CNGBG0  CNGBK2  CNHCKH  CNHCZN  CNJBW5  CNJBWZ  CNJC38  CNJC4K  CNJCD3  CNJCFR  CNJCMN  CNKBWP  CNKCC8  CNKCL3  CNLBR6  CNLCL3  CNLCW3  CNNCWF  CNPB1R  CNPBRH  CNPCLR  CPBC96  CPBCCR  CPBCRV  CPCBG9  CPCCMK  CPDBYC  CPDC07  CPDCC7  CNBBCV  CNCB6W  CNGBRY  CNHB95  CNNDCK  CNPB1T  CNPBML  CPBB3G  CPCBG8  CPCCBH  CPCCM1  CPCCMZ  CPFBKP
Codman Certas Programmable Valves used for hydrocephalus may not operate properly
Codman Certas Programmable Valve In Line Valve with Catheter and Accessories Product Code: 82-8801      Product Usage:  The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting.
Lot Codes:  CMBBP2  CMCBLG  CMDBHG  CMFBB8  CMHDFW  CMJCPY  CMLBLW  CMLCKP  CMMBCY  CMMC3F  CMNBFC  CMNCDW  CMPB96  CNCCLK  CNJBW0  CNJC4B  CNJC4W  CNKBWN  CNKCL1  CNLBR3  CNLBZF  CNMDM1  CNNCPL  CNNDH4  CNPBRM  CPBBGP  CPBC97  CPBCRW  CPCBHB  CPCCMP  CPDBYF  CPBCVD  CPDBYD    CPDBM1  CMBCB2  CMCBLH  CMDBHF  CMGBL5  CMJCMC  CMLBLY  CMNBZK  CNDCV1  CNHC8N  CNKB41  CNLBR5  CNMB2Z  CNMDNN  CNNCWG  CNPB1Y  CNPCLT  CPBCRY  CPFBK1    CLPCM9  CMBBB2  CMBBB3  CMDBHD  CMDCN7  CMDDJT  CMFBNK  CMFBNL  CMNBZG  CNDCP3  CNGBK5  CNHCZP  CNJB1F  CNJC4R  CNJCMP  CNKB0Y  CNLCL0  CNMCYY  CNMDNJ  CNNDH0  CNPBRK  CNPCLW  CPBBGR  CPCCBC  CPCCML  CPDCC2
Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Catheter and Accessories Product Code: 82-8803    Product Usage:  The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting.
Lot Codes:  CLPCM9  CMBBB2  CMBBB3  CMDBHD  CMDCN7  CMDDJT  CMFBNK  CMFBNL  CMNBZG  CNDCP3  CNGBK5  CNHCZP  CNJB1F  CNJC4R  CNJCMP  CNKB0Y  CNLCL0  CNMCYY  CNMDNJ  CNNDH0  CNPBRK  CNPCLW  CPBBGR  CPCCBC  CPCCML  CPDCC2
Codman Certas Programmable Valve In Line Valve only with SiphonGuard Device Product Code: 82-8804    Product Usage:  The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting.
Lot Codes:  CNMCDP  CNMDM2  CNMDNG  CNFCVJ  CNHB96  CNHC8L  CNHCZM  CNHCZT  CNJBWW  CNJBWY  CNJCFP  CNJCG9  CNKB0R  CNKBTR  CNKCL0  CNKCL2  CNLBR2  CNLBZD  CNMCDV  CNMDM3  CNNCWC  CNPB1W  CNPBRJ  CNPCLP  CPBB39  CPBBGN  CPBC98  CPBCKR  CPBCKT  CPCBG7  CPCCBG  CPDBYH  CPDC09  CPDCC4  CNBB13  CNCB6L  CNDB8B  CNDBVZ  CNDCM9  CNHC8J  CNHCKG  CNJC39  CNJC4H  CNJC4J  CNJCB0  CNDCM8  CNKB42  CNFCVH  CNHCZH  CNJB98  CNLCW4  CNMBFK  CNMCDW  CNMDNH  CNNCWH  CNNDH2  CNNDH3  CNPB1V  CPBB3H  CPBCR0  CPCBG6  CPCCBD  CPCCBF  CPDBYG  CPDCC6  CMMB1L  CMBC2W  CMDBHB  CMDDJP  CMDDJR  CMKB22  CMLCKR  CMMCR5  CMNBFD  CMNCVP  CMNCYM  CMPB95  CMPBMD  CNBBCZ  CNCB4R  CNCB61  CNMCDR  CPCCMW
Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Catheter and Accessories Product Code: 82-8805    Product Usage:  The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting.
Lot Codes:  CMBC2Y  CMDCN9  CMJC48  CMLC6D  CNCCLB  CNCCZ4  CNDBRG  CNDCNB  CNHC8M  CNJC4P  CNKCL4  CNLCL1  CNMB8Y  CNMDM0  CNNDHY  CNPCLZ  CPBC99  CPCC27  CPDBYJ  CMNBFF  CMNCDY  CNCB6M  CPBCRZ  CPDCKL
Codman Certas Programmable Valve In Line Valve with Siphonguard, Unitized Catheter and Accessories Product Code: 82-8806      Product Usage:  The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting.
Lot Codes:  CMJCMD  CMBC2Z  CMDB7C  CMJC49  CMBCPR  CMCC2T  CMDBHC  CMLBLZ  CMMB14  CNDBCY  CNDCV2  CNJCFT  CNKBH6  CNLB57  CNMDNL  CNNCWD  CNPB1Z  CPBB3J  CPBDBB  CPCCM0  CPDBYK
Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Unitized Bactiseal Catheter and Accessories   Product Code: 82-8807      Product Usage:  The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting.
Lot Codes:  CLPCNB  CMBCPT  CMCC2W  CMDB6L  CMDDJV  CMKB24  CMLCKN  CMMC3H  CMNBZH  CNCB6N  CNCCLJ  CNCCZ3  CNDB8C  CNDBRJ  CNGBK4  CNHCZR  CNJB1G  CNJC4T  CNJCMR  CNKBZD  CNLBVM  CNLBZC  CNMBFL  CNNDH1  CNMBFM  CNMDNK  CNPBRL  CNPCLV  CPBBGT  CNCCLH  CNCCZ2  CNDB69  CNDCV0  CPBCR3  CPCBHC  CPCBHD  CPDCC3  CMMCGV  CNBB11  CPBCR4  CPCCMN  CPDBYL
Worldwide Distribution-USA (nationwide) and the countries of  Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bulgaria, Bosnia-Herzegovina, Brazil, Belarus, Canary Islands, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, France, Germany, Great Britain, Greece, Guatemala, Honduras, Hungary, Iceland, India, Indonesia, Ireland, Israel, Iran, Italy, Jordan, Republic of South Korea, Kuwait, Kazakhstan, Latvia, Lebanon, Libya, Lithuania, Macedonia, Mexico, Malaysia, Malta, Nepal, Netherlands, Norway, Panama, Peru, Philippines, Pakistan, Paraguay, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Sri Lanka, South Africa, Switzerland, Turkey, Thailand, Taiwan, Uruguay, Usbekistan, Venezuela, Vietnam, and United Arab Emirates.
T3F, Free T3 Assay, REF/Catalog Number LKF31, Siemens Material Number (SMN) 10381626; an IVD Immunoassay kit for use with the IMMULITE/IMMULITE 1000 Analyzers --- Shipping or unit package: 100, 200, 500 and 600 test kits  --- Origin: UK  Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL55 4EL UK.   For the quantitative measurement of Free T3 in serum, as an aid in the clinical assessment of thyroid status.
Siemens Healthcare Diagnostics confirmed customer complaints regarding an increase in the number of euthyroid patients (those with normal function of the thyroid) demonstrating values above the recommended normal range as published in the Instructions For Use for the IMMULITE/IMMULITE 1000 and/or IMMULITE 2000/IMMULITE 2000 XPi for several lots of Free T3 kits.  A positive bias in quality control results was also observed, but the values may remain within the established ranges.
T3F, Free T3 Assay, REF/Catalog Number L2KF32 (200 tests), Siemens Material Number (SMN) 10381675, and REF/Catalog Number L2KF36 (600 Tests), SMN 10381682; an IVD Immunoassay kit for use with the IMMULITE 2000/IMMULITE 200 XPi Analyzers --- Origin: UK  Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL55 4EL UK.   For the quantitative measurement of Free T3 in serum, as an aid in the clinical assessment of thyroid status.
Worldwide Distribution - USA (nationwide) including Puerto Rico and the states  AL, AR, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KY, MA, MD, MN, MO, MS, NC, NV, NY, OH, OK, OR, PA, SC, TX, VT, WA, and WV., and the countries of   Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belgium, Brazil, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Lebanon, Netherlands, New Zealand, Norway, Oman, Panama, Philippines, Poland, Qatar, Romania, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Uzbekistan.
Brilliance iCT and Brilliance iCT SP   These systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. May include signal analysis and display equipment, patient and equipment supports, components and accessories
An artifact that resembles thrombus may appear on the image.
Worldwide Distribution - US Distribution including the states of DC, IL, IN, MI, MO, NY, OH, OR, PA, TX and VT., and the countries of  Australia, Belgium, China, Germany, India, Israel, Italy and The Netherlands.
Brilliance iCT, Brilliance 64 and Brilliance Big Bore   The Brilliance iCT, Brilliance 64 and Brilliance Big Bore are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
The DoseRight feature suggest a mAs based on the measured patient size, a reference size and a reference mAs.  When scanning large children, the suggested mAs may be higher than clinicians would expect.
USA (nationwide) Distribution including Puerto Rico.
User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System with software version 3.5.1 or lower   User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.
When utilizing the Routine Inventory screen to enter a User Defined Method (EMPTY) Flex the system may assign the User Defined Method Flex to a different Flex that is currently in inventory on the system, and then use the incorrect Flex Cartridge to process the user defined method.
Bean Paste Bread, Net Wt. 420 g, product is packaged within a plastic bag with twelve (12) bags per carton.
LSG Food World Inc., has recalled Bread Filled with Jam and Bean Paste Bread due to a misbranded product label (lacks english translation).
Bread Filled with Jam, Net Wt. 420 g, product is packaged within a plastic bag with twelve (12) bags per carton.
Lam Sheng Kee Fu Zhou Vermicell, Net Wt. 4.4 LB (2000 g), product is packaged in plastic bag with twelve (12) bags per carton.  UPC 6949682 803360; Manufactured by LAM SHENG KEE (HK) INTERNATIONAL LIMITED RM3. 8/F, YUEXIU BLDG.,  160-174 LOCKHART ROAD, WAN CHAI HK; Distributed by: S&M INT'L INC 100 Pulaski Street, Bayonne, NJ 07002, Product of China.
LSG Food World Inc., has recalled Fu Zhou Vermicelli  due to filth subject to Import Alert 02-02 and the product is misbranded in that it does not have English translation.
Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN  37849, Made in China.   Physical Therapy.
The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. This failure could result in temperature injuries to the treatment site; and there have been two reports of electric shock.
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blanket NS, REF T652NS, Rx only, Manufacturer  DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN  37849.   Physical Therapy.
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blnkt NS, REF T653NS, Rx only, Manufacturer  DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN  37849.   Physical Therapy.
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee Blanket w/ Straps NS, REF T654NS, Rx only, Manufacturer  DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN  37849.   Physical Therapy.
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Shoulder Blanket w/ Straps NS, REF T655NS, Rx only, Manufacturer  DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN  37849.   Physical Therapy.
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Foot/Ankle Blanket NS, REF T656NS, Rx only, Manufacturer  DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN  37849.   Physical Therapy.
Nationwide, Puerto Rico, Jamaica, and Grenada.
Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by: Alexion Pharmaceuticals, Inc., Cheshire, CT  06410, NDC 25682-001-01, UPC 3 25682-001-01 6.
Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.
US Distribution in states of: AZ, CA, DE, FL, LA, MD, MA, NJ, NY, OH, PA and TX.
Kimberly-Clark RadiOpaque Radiofrequency Cannula, Gauge 22, Length 100 mm, Active Tip 10 mm, Distributed in the US by Kimberly-Clark,Product code PMF22-100-10   The product is used to create lesions in nervous tissue when used with the Kimberly-Clark radiofrequency generator and probes.
55 cases (10 units per case = 550 units)
Product may contain a cannula with an active tip length of only 5mm rather than 10mm as indicated on the label.
Rhino 5 capsules(Spanish & English Labeling), 1 capsule per blister pack, Distributed by P&A Enterprise, Buena Park, CA  90621, English UPC 6 10708 10730 9, Spanish UPC 6 10708 10729 3.
2,395 blister packs total for all products
Marketed Without An Approved NDA/ANDA: FDA analysis found Rhino 5 which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine.  Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug.  Dapoxetine is an active ingredient not approved by the FDA.
MaXtremeZEN capsules, 1 capsule per blister pack, Distributed by: P&A Enterprise, Buena Park, CA  90621, UPC 6 10079 52468 2.
Marketed Without An Approved NDA/ANDA: FDA analysis found MaXtremeZEN which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine.  Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug.  Dapoxetine is an active ingredient not approved by the FDA.
eXtenZone capsules, 1 capsule per blister pack, Distributed by: P.M.C. Company, Buena Park, CA  90621, UPC 6 89076 49126 6.
Marketed Without An Approved NDA/ANDA: FDA analysis found eXtenZone which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine.  Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug.  Dapoxetine is an active ingredient not approved by the FDA.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distributed to California, Florida,  Oregon, Utah, and Mexico
Digestive, Enzyme Supplement, packaged 90 capsules per bottle, 135 capsules per bottle, or 270 capsules per bottle.  They are sold under brand Enzyme Research Products or Empower Life.
Digestive (90 count):  LOT #1206801, EXP 03/15 (means March 2015);    Digestive (135 count):  LOT # 1108103, EXP 03/14 (means March 2014);  LOT# 1234006, EXP 12/15 (means December 2015) for Empower Life Nutrition brand.    Digestive (270 count):   LOT# 1127002, EXP 09/14 (means September 2014);  LOT# 1120606, EXP 07/14 (means July 2014);  LOT# 1113201, EXP 05/14 (means May 2014);  LOT# 1029104, EXP 10/13 (means October 2013);  LOT# 1215601, EXP 06/15 (means June 2015);  LOT# 1234006, EXP 12/15 (means December 2015).
1199 bottles of 90 ct; 2081 bottles of 135 ct; 9799 bottles of 270 ct;
Dietary supplement products are recalled because they were made from ingredient that was contaminated with Chloramphenicol.
B-Complex with Enzymes, Vitamin/Enzyme Supplement.  Packaged 60 vegetable capsules per bottle.  They are sold under brand Enzyme Research Products.
B-Complex Plus. They are sold under brand Enzyme Research Products
Glucosamine, Chondroitin, MSM Plus, dietary supplement, 60 capsules per bottle.  They are sold under brand Enzyme Research Products or Empower Life Vital Joints brand.
Zinc Plus, Mineral/Enzyme supplement, 90 vegetable capsules per bottle.  They are sold under brand Enzyme Research Products.
Digestaze, dietary supplement, 90 vegetable capsules per bottle.  They are sold under brand DESBIO
Enzyme Formula, dietary supplement, 100 capsules or 250 capsules per bottles, sold unlabeled to Rich Distributing.
200 bottles (100 ct); 367 bottles (250 ct)
XymoZyme, dietary supplement, packaged 60 capsules per bottte, 120 capsules per bottle,  sold under brand ZYMOGEN.
Digest Ultra, dietary supplement, packaged 56 capsules per bottle or distributed in bulk, sold under brand YOR.  Product distributed OUTSIDE the US has Spanish label.
82,906 bottles and 1,552,319 capsules (bulk) in US and 62766 bottles OUTSIDE the US
California Girl canned Peach Halves in Juice, 6 cans per case.   UPC 52391 72992
Atlapac Trading Co. is recalling California Girl canned Peach Halves because they were reported to be swollen.
KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-30, UPC 3 0168-0099-30 9.
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
Shortbread Almond Crescent cookies sold under the Lambs Farm brand and packaged in a plastic bag with a net weight of 10 oz.
All batches coded with dates 7/1/2013 through 11/14/2013.
The labels do not declare milk, soy, and wheat allergens.
Double Chocolate Butter Cookies sold under the Lambs Farm brand and packaged in a plastic bag with a net weight of 10 oz.
10 oz packages: 111 bags; 7 lbs bulk packages: 1 bag
The labels do not declare milk and wheat allergens.
Famous Butter Cookies sold under the Lambs Farm brand and packaged in a plastic bag with a net weight of 10 oz.
10 oz packages: 491 bags; 7 lbs bulk packages: 1
Lemon Butter Cookies sold under the Lambs Farm brand and packaged in a plastic bag with a net weight of 10 oz.
10 oz packages: 342 bags; 7 lbs bulk packages: 1 bag
Snowball Cookies sold under the Lambs Farm brand and packaged in a white metal tin with a net weight of 1 lb.
Cheerful Cookie Combo containing an assortment of Lemon Butter Cookies and Famous Butter Cookies sold under the Lambs Farm brand and packaged in a white metal tin with a net weight of 1 lb.
Raspberry Swirl Bread loaf sold under the Lambs Farm brand and packaged in a plastic bag with a net weight of 8 oz. This product was only sold as a part of the Bread Trio gift box.
The labels do not declare soy allergens.
Banana Nut Bread loaf sold under the Lambs Farm brand and packaged in a plastic bag with a net weight of 8 oz. This product was only sold as a part of the Bread Trio gift box.
Blueberry Bread loaf sold under the Lambs Farm brand and packaged in a plastic bag with a net weight of 8 oz. This product was only sold as a part of the Bread Trio gift box.
American National Red Cross Southeastern Michigan Region
Blood product, which was incorrectly labeled with respect to the red cell antigens, was distributed.
Worldwide Distribution-USA (nationwide) including the states of AL, CO, FL, IN, KS, KY, MN, NC, OH, TX, and VA, and the countries of ALGERIA, AUSTRALIA, BELGIUM, BULGARIA, CANADA, CHINA, ABIDJAN COTEDIVOIRE EGYPT, FRANCE, GERMANY, GREAT BRITAIN, INDIA, IRAQ, ITALY, JAPAN, KENYA, LATVIA, LEBANON, MALAYSIA, MARTINIQUE,MOROCCO, NEW ZEALAND, NORWAY, PAKISTAN, POLAND, PORTUGAL ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWITZERLAND, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, and VIETNAM.
GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems.     Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
There is an issue with the Manual Film Composer feature on some CT products.  There is an opportunity, while following a specific workflow, to create a film image with one patient's images and another patient's name in the footer.  This is also an issue when within Manual Film Composer, if a color image is selected for printing, another patient's black and white image appears in the preview screen and the color image cannot be printed.
Blood products, which tested negative for West Nile Virus (WNV) using pooled testing, but were not tested for WNV by individual donor testing, were distributed.
Blood Systems, Inc. dba United Blood Services Texas
Blood product, for which the additive solution was not added during manufacturing, was distributed.
Mercuroclear Antiseptic Anesthetic First Aid Helps prevent infection and relieves pain and itching of minor cuts, scrapes, burns and insect bites.  Aqueous solution. Active Ingredients Benzalkonium chloride 0.13% - First Aid antiseptic, Lidocaine hydrochloride 2.5% - External analgesic. Sold under the following brands: a) Good Neighbor Pharmacy NDC 24385-593-46 , b) Quality Choice, NDC 63868-0488-02; c) Select Brand NDC 15127-885-59; d) Premier Value UPC 4098602556; e) Rite Aid Pharmacy UPC 011822576871; f) TopCare UPC 3680033436; g) Vida Mia UPC 847717060718; h) Humco 2 fl. oz NDC 0395-1637-92 i) Humco 3 fl. oz. NCD 0395-1637-93 ; 2 fl OZ (59 mL) and 3 FL OZ (90 mL) bottles, HUMCO, Texarkana, TX 75501.
a) Good Neighbor Pharmacy Mercuroclear  2 fl. oz, Lots: ALL LOTS   b) Quality Choice Mercuroclear  2 fl. oz, Lots: ALL LOTS    c) Select Brand Mercuroclear  2 fl. oz, Lots: ALL LOTS    d) Premier Value Mercuroclear  2 fl. oz, Lot: ALL LOTS    e) Rite Aid Mercuroclear  2 fl. oz, Lots: ALL LOTS    f) Top Care Mercuroclear  2 fl. oz , Lots: ALL LOTS    g) Vida Mia Mercuroclear, 2 fl. oz. Lots: ALL LOTS    h) HUMCO Mercuroclear 2 fl oz. sold to WalMart Lots: ALL LOTS     i) HUMCO Mercuroclear 3 fl. oz. Lots: ALL LOTS
Microbial Contamination of Non-Sterile Product(s): The product was found to be contaminated with Bulkholderia sp.
Worldwide Distribution - USA (nationwide) and Internationally to U.S. Nationwide; Algerie, Argentina, Armenia, Australia, Austria, Azerbaidjian, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bolivia, Brazil, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroon, Canada, Chad, Chile, China, Colombia, Democratic Republic of Congo, Costa Rica, Cote d'Ivorie, Germany, Czech Republic, Dominican Republic, Dutch Antilles, Dutch Antilles, Ecuador, Egypt, Republica De El Salvador, Estonia, Germany, Ethiopia, France, Gabon, Georgia, Germany, Greece, Guatemala, Guinea, Herzegovina, Honduras, Hungary, India, Germany, Indonesia, Iraq, Israel, Italy, Jamaica, Japan, Iraq, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malaysia, Malaysia, Mali, Malta, Mexico, Romania, Mongolia, Morocco, Mozambique, Singapore, Netherlands, Managua, Niamey Niger, Nigeria, Nigeria, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Uganda, Kingdom of Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sudan, Sweden, Switzerland, Syria, Tanzania, Italy, Thailand, Trinidad & Tobago, Tunisia, Turkey, Uganda, Ukraine, UAE, United Kingdom, Uruguay, Venezuela, Vietnam, Vietnam, Yemen and Zimbabwe
ZYM B Reagent (REF 70493)   ZYM B reagent is an additional test used to reveal the results of some miniaturized biochemical test included in the API strips. The API product line is a standardized system combining several biochemical tests, which enables group or species identifications of microorganisms.
39439 kits (includes ZYM B reagents, API Listeria * API NH kits)
bioMrieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493); leading to a false negative results of some API biochemical tests using the ZYM B reagent.
API Listeria (REF 10300)   API Listeria is a standardized system for the identification of Listeria which uses miniaturized tests, as well as a database. The ZYM B reagent is including in API Listeria kit and it is used as an additional reagent for revealing the result of DIM miniaturized biochemical test included in the API Listeria strips. ZYM B reagent is added in the DIM test before reading miniaturized biochemical test including in the API Listeria strips.
API NH (REF 10400)   API NH is a standardized system for the identification of Neisseria, Haemophilus (and related genera) and Moraxella catharrhalis (Branhamella catarrhalis), which uses miniaturized tests, as well as a specially adapted database. API NH also enables the biotyping of Haemophilus influenza and Haemophilus parainfluenxzae, as well as the detection of a penicllinase.
Blood products, for which the platelet yield was not sufficient to support the products being split into two parts, were distributed.
Aurora Area Blood Bank Dba Heartland Blood Centers
Red Blood Cells Frozen Leukocytes Reduced
Blood product, which was incorrectly labeled as negative for the S red cell antigen, was distributed.
American Red Cross Blood Svs. Indiana-Ohio Region
Blood products, collected from a donor with a history of Hepatitis A exposure, were distributed.
Blood product, with a low platelet count, was distributed.
Blood product, which did not meet the minimum requirement for Red Blood Cell recovery following leukoreduction, was distributed.
Blood Systems, Inc. DBA United Blood Services
Blood product, for which the quality control testing for the Hemoflow shaker was not documented, was distributed.
BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b) 90 count bottle (NDC 0591-3331-19), c) 500 count bottle (NDC 0591-3331-05),  Manufactactred By: Watson Laboratories, Inc. Corona, CA 92880
Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.
Hydravax High Potency Diuretic Weight Loss Solution, Pharmaceutical Grade, 45 capsules per bottle, Dietary Supplement, Manufactured and Distributed by Metabolic Nutrition, Sunrise, Florida, www.metabolicnutrition.com
Marketed Without an Approved NDA/ANDA; this product is being recalled for containing an undeclared diuretic called Triamterene, an FDA approved prescription only medication used to treat edema, making it an unapproved new drug
Worldwide Distribution - US Nationwide including (Puerto Rico) and the countries of: Spain, Germany, Australia, Peru, Mexico, Colombia, South Africa, and Israel.
Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver,      Product Usage:  The Modular Screw Driver is used for inserting a modular bone screw into the pedicle during a spinal fixation procedure. It is a reusable instrument.
Production Identification Numbers:  Part Number 52-1332, All Lot Numbers.
Orthofix received 6 complaints which resulted in reportable events due to extended surgical times greater than 30 minutes for the Modular Screw Driver (PN 52-1332). The complaints alleged that the screw driver's collet would malfunction resulting in the surgeon being unable to use the Modular Screw Driver to effectively place Modular Screws, which may result in a delay of surgery.
Worldwide Distribution - US (Nationwide) including DC and PR, except DE, SD, ND, and VT; and Internationally to: Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bermuda, Bolivia,Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic ,Denmark, Ecuador, Egypt, El Salvador, Estonia ,Finland, France, Germany, Greece,Guam, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kuwait,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malaysia, Malta, Mexico, Morocco, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, United Republic of Tunisia, Turkey, United Arab Emirates, United Kingdom, Venezuela, Uruguay.
GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850.   The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and mixed venous oxygen saturation), impedance respiration, airway gases (CO2, O2, N2O and anesthetic agents), spirometry, gas exchange, and neurophysiological (including electroencephalography, Entropy, Bispectral Index (BIS) and neuromuscular transmission) status. The CARESCAPE Monitor B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE Monitor B650 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The CARESCAPE Monitor B650 is not intended for use during MRI. The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 system is indicated for monitoring of Hemodynamic (including ECG, ST Segment, Arrhythmia Detection, ECG Diagnostic Analysis and Measurement, Invasive Pressure, Noninvasive Blood Pressure, Pulse Oximetry, Cardiac Output, Temperature, Impedance Respiration and SvO2 (Mixed Venous Oxygen Saturation), Airway Gases (Fi/Et C02, 02, N20 and Anesthetic
GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE Monitor B850 and CARESCAPE Monitor B650. These included 25 issues related to  NIBP (Non-InvasiVentilation Alarms:ve Blood Pressure) , ECG, Central Monitor, General, Tram, and  Bed to Bed Issues.
US: Nationwide (AR, FL, IA, ID, IN, MI, MN, MO, MT, NC, ND, OH, PA, TX, UT, VA, WI, WY)
The PLASMACELL-C disposable set in overpouch is a single unit open system consisting of the PLASMACELL-C separation device (containing the membrane filter), the reinfusion reservoir, two (2) transducer protectors, two (2) solution spikes, one (1) female Luer for plasma container connection and one (1) male Luer for needle connection.
PLASMACELL-C Disposable Set for Use with SPIKESMART System, with a defect in the base of the blue vent cap on the reservoir assembly that may result in a leak of the reservoir assembly, was distributed.
US Distribution in states of: GA, IL, KY, MI, MO, NJ, TN, UT and VA.
Teflon Tube, sterile  T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5  24232 Sconkidrchen, Germany    distributed in the USA by: Stryker Howmedica Osteonics Corp.: Mahwah, NJ 07430 USA    510 K042396    Used in several T2 systems intended to support the exchange of the Ball Tip Guide Wires for Smooth Tip Guide Wires: T2 Tibial Nailing Systems, T2 Femoral Nailing Systems, T2 Ankle Nailing Systems, and T2 Humerus Nailing Systems
Catalog Number 1806-0073S Lot Code K06C3B4, K05ECF3, K05ECF2, K057298, K0432D3
Stryker became aware during laboratory testing that there is a potential that the seal integrity of the outer pouch (sterile barrier) may be compromised for certain lots of the product Teflon Tube, sterile.
Nationwide Distribution including TX, IL, and GA.
Carestream DRX Evolution System (Standard Q)   The DRX-Evolution System (Standard Q) is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstandbucky to complete x-ray exposures.
Carestream received a report of an exposure being initiated without a patient image captured. The patient was imaged 2 times before an image was captured. The field engineer who visited the site reported the system allowed an exposure without the assignment of a bucky or image receptor.
Sterile Diluent for Allergenic Extracts, 10% Glycerin w/v, 9 mL vial packaged in 25-count vials per carton, Rx only, Greer Laboratories, Inc., Lenoir, NC  28645; Item SG2507192.
Sterile Diluent for Allergenic Extracts, with lack of assurance of sterility, was distributed.
US: Nationwide (AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY,LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV); FOREIGN: Austria, Belgium, Canada, Finland, France, Germany, Ireland, Netherlands, Spain, Switzerland, United Kingdom
OroCAM is supplied in three glass vial sizes containing 6 mL, 11 mL and 33 mL of meloxicam. Each vial has a different metered dose pump delivering a dose of 0.25 mg, 0.50 mg, or 1.075 mg, per spray, respectively. Manufactured for Abbott Laboratories; North Chicago, IL 60064 USA; Product of Spain
*** US PRODUCTS ***    1) 6 mL Vials. List Number 04943-04-01. Lot Codes and Expiration Dates: EMFG, 11/2014; FBDN, 02/2015; FEBU-3, 05/2015, FEBU-1, 05/2015.     2) 11 mL Vials. List Number 04943-04-02. Lot Codes and Expiration Dates: EMFF, 11/2014; FEBU-2, 05/2015.     3) 13 mL Vials. List Number 04943-04-03. Lot Codes and Expiration Dates: EMFG-1, 11/2014; EMGL, 11/2014; EMGM, 11/2014, EMGN, 11/2014.    *** FOREIGN PRODUCTS ***     4) 6 mL Vials. List Number 04943-90-01. Lot Codes and Expiration Dates: EDEG-2, 05-2014; EKFE, 9-2014.     5) 6 mL Vials. List Number 04943-27-01. Lot Codes and Expiration Dates: EDEG, 05-2014.     6) 6 mL Vials. List Number 04943-03-01. Lot Codes and Expiration Dates: 33008XN, 10-2015.; 33004XN, 10-2015.     7) 11 mL vials. List Number 04943-90-02. Lot Codes and Expiration Dates: EDEG-3, 05-2014; EFKE-1, 09-2014.     8) 11 mL Vials. List Number 04943-27-02. Lot Codes and Expiration Dates: EDGE-1, 05-2014.     9) 33 mL Vials. List Number 04943-27-03. Lot Codes and Expiration Dates: EDEH, 05-2014; EDEF, 04-2014; EHGM, 08-2014.     10) 33 mL Vials. List Number 04943-90-03. Lot Codes and Expiration Dates: EFFW, 06-2014; EHEK, 09-2014.
*** US PRODUCTS *** 6 mL Vials: 14,527 vials. 11 mL Vials: 14,104 vials. 33 mL Vials: 13,306 vials.
Abbott Animal Health is voluntarily recalling the ten lots of OroCAM (meloxicam) Transmucosal Oral Spray for Dogs due to the possibility that some animals could receive an incorrect dose during administration. A limited number of units from lots FEBU-2 and FEBU-3 were found to contain incorrect pumps.
Worldwide Distribution - US (Nationwide) and Internationally to: Canada and Japan.
Compressor Mini   To provide a supply of dry, filtered compressed air for a medical respiratory ventilator or anaesthesia machine that meet the specifications of the compressor mini. compressor mini is intended to be operated by healthcare providers, physicians, nurses, and technicians. Compressor mini is to be used only for bedside application within the hospital environment. Compressor mini is neither intended nor suitable for use during in-hospital patient transportation or during ambulance or air transportation. Compressor mini is not suitable for use with MRI.
Maquet Compressor Mini may deliver compressed air at a temperature higher than specified.
US Distribution in the states of:  Arizona, Georgia, Illinois, Indiana, Utah, and Wisconsin.
The ACUTE Innovations Modular RibLoc System (RibLoc U plus) is comprised titanium plates and screws that are used to stabilize rib fractures, fusions and osteotomies during the normal bone healing process.     The plates are manufactured from titanium and the screws are manufactured from titanium alloy.  Surgical instrumentation is supplied with the implants in a surgical tray to facilitate the proper insertion of the plates and screws.    The ACUTE Innovations Modular RibLoc System is intended to stabilize and provide fixation for fractures, fusions, and osteotomies of the ribs, and for reconstructions of the chest wall and sternum.    Part Numbers:    RBL1301- 50 mm Rib Plate;   RBL1302- 75 mm Rib Plate;   RBL1303- 115 mm Rib Plate;  RBL1304- 155 mm Rib Plate;   RBL1305- 215 mm Rib Plate;
The ACUTE Innovations Ribloc U plus Rib Fracture Plating System is recalled because it has the potential to malfunction during installation in a surgery.
US Nationwide Distribution in the states of CA, CT, DC, MA, NJ, NY, PA, MD, VA, WV, NC, GA, FL, TN, OH, MN, MT, IL, MO, NE, OK, TX, NM, and WA.
Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plastic Port/F, Product Number H965450140, Catalog Number 45-014;  2) 8F/SL/Titanium Ports/NF, Product Number H965450170, Catalog Number 45-017; 3) 6F/SL/Plastic Port/F, Product Number H965450200, Catalog Number 45-020; 4) 8F/SL/Plastic Port/F, Product Number H965450220, Catalog Number 45-022; 5) 8F/SL/Titanium Ports/F, Product Number H965450250, Catalog Number 45-025; 6) Plastic/6F/non-filled/non-valved, Product Number H965450290, Catalog Number 45-029;   7) Plastic/6F/filled/non-valved, Product Number H965450300, Catalog Number 45-030; 8) Plastic/8F/non-filled/non-valved, Product Number H965450310, Catalog Number 45-031; 9) Plastic/8F/filled/non-valved, Product Number H965450320, Catalog Number 45-032; 10) Plastic/6F/non-filled/valved,  Product Number H965450370, Catalog Number 45-037;   11) Plastic/6F/filled/valved, Product Number H965450380, Catalog Number 45-038; 12) Plastic/8F/non-filled/valved, Product Number H965450390, Catalog Number 45-039; 13) Plastic/8F/filled/valved, Product Number H965450400, Catalog Number 45-040; 14) Titanium/6F/non-filled/valved, Product Number H965450410, Catalog Number 45-041; 15) Titanium/8F/non-filled/valved, Product Number H965450430, Catalog Number 45-043.      Product Usage:  ***K-Shield Port Access Infusion Set, (affected product) supplied by Kawasumi Laboratories. The K-Shield Port Access Infusion Set with High Pressure Tubing is an intravascular administration set with a non-coring Huber needle that is used to access an implanted medication port for solution infusion. This device is also indicated for injection of contrast media by a power injector only with power injectable implanted port.***NMI Port is indicated for patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.
Navilyst Medical has recalled a Port Kit with Access Infusion Set due to a possible breach of sterilization barrier.
Worldwide Distribution-USA (nationwide) and the countries of  Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.
Standard tubing set, Synergetics, Inc., length 10 ft, sterile / EO, 17570. Packed 6 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
23ga Chow Illuminated Pick, Synergetics, inc., length 7.5 ft, sterile / EO, 56.07.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
Stiff 25ga Chow Illuminated Pick (Dull), Synergetics, inc.,  length 8.0 ft, sterile / EO, 56.07.25PS. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
Chandelier Infusion Cannula, Synergetics, inc., 20ga, length 7.5 ft, sterile / EO, 56.30.P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
23ga Chandelier Infusion Cannula, Synergetics, inc., length 8.0 ft, sterile / EO, 56.30.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
25ga Awh Chandelier, Synergetics, inc., length 8.0 ft, sterile / EO, 56.50.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
29ga Oshima Dual Chandelier, Synergetics, inc., length 7.5 ft, sterile / EO, 56.50.29P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
25ga Awh Chandelier, Synergetics, inc., B&L Cannula Compatible, length 8.0 ft, sterile / EO, 56.52.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
25ga Awh Vivid Chandelier, Synergetics, length 7.5 ft, sterile / EO, 56.54.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
27ga ONE-STEP (tm) Awh/Tano Vivid Chandelier, Synergetics, length 8.0 ft, sterile / EO, 56.55.27P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
23ga Straight Fixed Extended Illuminated Laser Probe, Synergetics, length 7.5 ft, sterile / EO, 55.62.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
Endo Illuminator, Synergetics, inc., 20ga, length 7.0 ft, sterile / EO, 56.02. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
23ga Endo Illuminator (Eckardt Trocar Compatible), Synergetics, inc., length 8.0 ft, sterile / EO, 56.02.23P Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
25ga Endo Illuminator, Synergetics, inc., length 7.0 ft, sterile / EO, 56.02.25 Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
Stiff 25ga Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.02.25PS. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
27ga ONE-STEP (tm) Endo Illuminator, Synergetics, inc.,  length 7.5 ft, sterile / EO, 56.02.27P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
''The Corona'' Shielded Wide Field Endo Illuminator, Synergetics, inc. 20ga, length 7.0 ft, sterile / EO, 56.12. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
23ga Wide Field Corona Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.12.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
25ga Wide Field Corona Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.12.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
Two-Port Vitrectomy (TPV (tm)) Wide Field High Flow End Irrigator, Synergetics, inc., 19ga, length 7.0 ft, sterile / EO, 56.14. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
Vivid (tm) Endo Illuminator, 20ga, Synergetics, inc., length 7.5 ft, sterile / EO, 56.20P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
Wide Field Endo Illuminator, Vivid (tm) Endo Illuminator, 20ga, Synergetics, inc., 20ga, length 7.5 ft, sterile / EO, 56.21P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
23ga Wide Field Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.21.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
Stiff 25ga Wide Field Endo Illuminator, Synergetics, inc. length 7.5 ft, sterile / EO, 56.21.25PS. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
23ga Mid-Field Endo Illuminator, Synergetics length 7.5 ft, sterile / EO, 56.22.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
25ga Mid-Field Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.22.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
23ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.24.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
25ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.24.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
Worldwide Distribution - US (Nationwide) and PR; and Internationally to: Italy, Australia, Saudi Arabia, UK, China, Canada, Germany, New Zealand, Columbia, Korea, and Chile.
Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container. Sterilization container systems manufactured and distributed under the following names: Small  Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Small Perforated Bottom, REF 50-8731, 270mm x 270mm x 100mm, QTY:  1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN  37013    Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Small Perforated Bottom, REF 50-8732, 270mm x 270mm x 135mm, QTY:  1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN  37013    Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Small Perforated Bottom, REF 50-8733, 270mm x 270mm x 150mm, QTY:  1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN  37013    Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Small Perforated Bottom, REF 50-8734, 270mm x 270mm x 200mm, QTY:  1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN  37013    Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Small Perforated Bottom, REF 50-8735, 270mm x 270mm x 260mm, QTY:  1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN  37013    Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Small Non-Perforated Bottom, REF 50-8744, 270mm x 270mm x 100mm, QTY:  1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN  37013    Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Small Non-Perforated Bottom, REF 50-8745, 270mm x 270mm x 135mm, QTY:  1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN  37013    Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Small Non-Perforated Bottom, REF 50-8746, 270mm x 270mm x 150mm, QTY:  1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN  37013    Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Small Non-Perforated Bottom, REF 50-8747, 270mm x 270mm x 200mm, QTY:  1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN  37013    Symmetry and CODMAN(R) bran
The Quad-Lock(TM) Sterilization Container System may not maintain an effective sterile barrier.
Worldwide Distribution - USA including CA, CO, IN, KY, MD and TX and Internationally to Japan, Taiwan, United Kingdom, Sweden, and Germany.
AnspacSingle use Sterile bone cutting burs.h REF: S-1504TD Twist Drill for 1.5mm x 4mm screw. Rx only  Single use Sterile bone cutting burs.
Cutter was longer than was stated on the label.
Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw.  Rx only   Single use Sterile bone cutting burs.
CA only - all but 2 sales were cash and carry.
Hnos. Perez brand cactus leaves (pads):   distributed by:  West Coast Produce  300 Franklin St.  Oakland, CA 94607
State of California, Department of Pesticide  Regulation samples Cactus Pads and found the following pesticides that are not permitted in the US: Permethrin - 0.094 ppm; Chlorpyriphos - 0.136 ppm; Monocrotophos - 0.030 ppm.
Mexpogroup Cactus Grown in Mexico; 44 lbs, 20 KG;  Calle El Rosario  #20581 Col Buenos Aires Norte C.P. 22700  Tijuana, Mexico.
CA Dept of  Pesticide Regulation, Enforcement Branch, sampled Mexpogroup Cactus and found the following chemical which do not have a tolerance level in the US: Monocrotophos - 2.37 ppm;  Carbendazim as Thiophanate Methyl - 0.154 ppm;  Chlorothalonil - 3.61 ppm.
worldwide Distribution - US (Nationwide) including states of: IN, PA, MD, MI, NY, GA, MN, OK, VA, TX, WI, CA, IL, TN, WA, NC, SC, MA, NJ, and KY; and Internationally to: Canada, New Zealand, South Korea, Australia, Hong Kong, Saudia Arabia, Guinea, Kuwait, Israel, Oman, South Africa, China, UK, Sweden, Poland, Denmark, Germany, Finland, Czech Republic, Italy, France, Portugal and Spain.
KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608.  Made in U.S.A.
164 units Total (42 domestically & 122 internationally)
Carestream Health, Inc. has recalled DR 7500 Dual Detector System utilizing Version 5.X Software due to a possible patient image display error.
Worldwide Distribution - US (Nationwide) and PR; and Internationally to:BE, ES, FI, GB, NL, SE, AR, AT, AU, CA, CH, CN, CR, EG, HK, ID, JO, JP, KR, KW, LB, LY, MM, PL, RO, RS, RU, SG. TH, TN, TR, TW, UA, VN, and ZA.
S5/C5 Heart-lung machine   Product Usage:  The StOckert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
Sorin is initiating a field correction on S5/C5 Heart-lung machine and CP5 centrifugal pump system due to reports of pump speed control knob failures resulting in no response.
CP5 centrifugal pump system   Product Usage:  The Stockert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
US Distribution in the states of CA, NC, TX, IN, NJ, and MI.
SET SCREW RETAINING DRIVER, REF 3010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc., 1800 Pyramid Place, Memphis, TN  38132.   Screwdriver - orthopedic manual surgical instrument.
The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not allow proper mating between the Set Screw Retaining Drive and the set screw.
Uncle Ben's (R), Infused(R) Rice Mexican Flavor rice, NET WT 5 LB (2.27 kg), distributed by MARS Foodservices US, P.O. Box 5059, Rancho Dominguez, CA  90224-5059
The firm received reports of flushing reactions after consumption of product led to concern of possible production issue.
Condies Food fine shred lettuce, and 1/4 shred lettuce; 5 lbs bags, 4 bags per case
Fine shred lettuce 1-7; 1/4 shred lettuce 1-6
Fine shred lettuce (1-7): 90 cases; 1/4 shred lettuce (1-6): 28 cases
A piece of hard brittle plastic was found inside a bag of 41890 Lettuce Shred Fine. The bag of lettuce had the following code date: Use Thru 1/7. Upon receipt of a picture of the plastic, it was determined that the plastic had originated from an instrument used by Condies Foods for quality control purposes. It is believed that there is a possibility that additional pieces may be within other bags of product. As a precaution, Condies Foods has decided to recall any product which potentially may have been affected.
Worldwide Distribution - USA including NJ, TX, WV, MN, GA, and Internationally to Mexico and Japan.
Radial Assist RAD BOARD, used to support the weight of a patient's arm and supplies for a medical procedure.    The Merit RAD BOARD is a rigid and stiff body board intended for use for various medical purposes. RAD BOARD was specifically designed to support the weight of a patient's arm and supplies for medical procedure, in order to have optimal access to upper extremity vasculature, including radial and brachial arterial and venous access. The RAD BOARD is partially lined with a layer of lead-free Xenolite TB for additional radiation scatter protection.
Merit Medical Systems, Inc. is voluntarily recalling one lot (B507171) of RAD BOARD RB 100 devices. The affected devices are missing the main label which graphically depicts patient orientation on the board. The issue may allow the board to be oriented in the wrong direction where the semi-radiopaque material in the board (embedded Xenolite) could obscure patient anatomy during fluoroscopy. There have been no reports of patient harm or injury from Merit customers as a result of this issue. Merit has chosen to remove this lot from the field by replacing the unlabeled RAD BOARDs.
Worldwide Distribution-USA (nationwide) and the countries of  Thailand, Japan, Hong Kong, Morocco, and UAE.
Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008.   Class II, 510(k) K13227.
Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant, Catalog TSVWB11, Lot 62470008, because some of the packages of this lot may have the Cap Label state 3.7 x 10mm instead of 4.7 x 11.5mm.
AL, AR, AZ, CA, CO, FL, GA, IL, KY, MN, MO, MS, NC, NH, NY, PA, TX, VA, and WA.
Walmart Great Value Tex Mex Trail Mix, Net Wt 28 oz (793g), Distributed by Wal Mart Stores, Inc., Bentonville, AR, packed in rigid clear plastic jars.
55,717 cases (6/28 oz clear plastic jars per case)
Product contains undeclared allergen; milk.
Worldwide Distribution - US (nationwide) and the countries of Albania, Australia, Austria, Bangladesh, Belgium, Bosnia Herzeg, Brazil, Brunei, Canada, Columbia, Denmark, Ecuador, Egypt, Finland, France, Germany, Iceland, India, Israel, Italy, Japan, Kuwait, Malaysia, Mauritius, Mexico, Netherlands, Norway, Oman, P.R. China, Philippines, Poland, Qatar, Rep of Yemen, Republic Korea, Romania, Russian Fed. San Marino, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E. United Kingdom and Venezuela.
ACUSON SC2000 Ultrasound System; Power Input: 100-240VAC, 1600W Max, 50/60 Hz.    Manufacturer:  Siemens Medical Solutions USA, Inc.  685 East Middlefield Road  Mountain View, CA 94043    SC2000 ultrasound imaging system is intended for Cardiac, neo-natal and fetal cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal interoperative, Intraoperative Neurological, Musculo-skeletal Conventional and musculo-skeletal Superficial Applications. The system also provided the ability to measure anatomical structures and calculation packages that provide information to the clinician that my be used adjunctively and with other medical data obtained by a physician for clinical diagnosis purposes.
The user interface assembly on the ACUSON SC2000  may become loose with the potential for the entire module to fall off of the ultrasound system.
Worldwide Distribution - US (Nationwide) including states of: NY, MA, NJ, OH, CA, HI, CO, MN, FL, PA, IA, WI, AZ, TX, TN, IL, SD, MO, NM, AR, WV, MI and Internationally to: Sweden, Israel, Canada, Kamnick, and Slovenia.
Simplexa'' Flu A/B & RSV Direct assay, Model MOL2650.   The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C.
Focus Diagnostics is initiating an urgent safety notice correction for Simplexa Flu A/B & RSV Direct assay (MOL2650) because Focus Diagnostics has received some customer complaints of Simplexa Flu A/B & RSV lots due to sporadic false positive RSV signals, which may result in a higher RSV false positive rate.
Worldwide Distribution-USA (nationwide) and the countries of  Australia, Austria, Canada, Ecuador, Finland, France, Germany, India, Ireland, Israel, Italy, Japan, Mexico, P.R. China, Philippines, Portugal, Republic Korea, Russian Fed. Saudi Arabia, Serbia, South Africa, Spain, Suriname, Sweden, Taiwan, Turkey, U.A.E., and United Kingdom.
ACUSON SC2000 Power Input: 100-240VAC, 1600 Max 50/60Hz;    Siemens Medical Solutions USA, Inc.  685 East Middlefield Road  Mountain View, CA 94043    Ultrasound imaging system.
The locking mechanism that is intended to hold the control panel in a fixed position can become loose and fail to lock the rotation of the control panel, making it unable to steer or control during transport.
Simply balanced, herb mixed freeze dried vegetables all natural, Ingredients: Super sweet corn, edamame, peas, carrots, (carrots, sugar, dextrose, tapioca starch),  Italian seasoning (Garlic, tomato (tomato, salt), crushed red pepper, basil, oregano), coconut oil, sea salt. May contain peanut, tree nuts, milk, soy, and wheat., Net WT 2.5 oz (71 g), UPC 0 85239 08318 5, distributed by Target Corporation, Minneapolis, MN 55403.
Amport Foods is recalling a  limited amount of Target Simply Balanced Herb Mixed Freeze Dried Vegetable due to a potential for undeclared soy.
Worldwide Distribution: US (nationwide) including states of: AZ, CA, FL, GA, IA, IL, LA, MA, ME, MI, MO, MS, NY, PA, SC, TN, TX, VA, and Puerto Rico; and Internationally to: Canada, Chile, and Panama.
ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C.   Model 96281 is intended for use with either adult or neonatal patient  populations in a hospital environment.
1057 units (988 in the US and 69 outside of the US).
The AriaTele Model 96281 with SpO2 monitoring Option C is recalled because the AriaTele (transmitter) display and the Telemetry Central Station display may show a SpO2 value when the sensor is not connected to the patient or in certain sensor failed conditions.
Worldwide Distribution - USA (nationwide) and Internationally to IN, AU, CN, AR, BE, PE, KR, BR, CO, SG, TH, BN, HK, JP, and CA.
BD BACTEC FX- Top Unit instrument, catalog number 441385, and Bottom Unit instrument, catalog 441386, available as a single or a stack configuration; Manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152.   The BD BACTEC FX instrument is designed for the rapid detection of bacteria and fungi in clinical specimens. Samples are drawn from patients and injected directly into BACTEC culture vials, which are placed into the instrument for incubation and testing.
Improperly functioning component of a diagnostic medical device may cause false negative results in clinical specimens.
BD BACTEC FX 40 instrument, catalog number 442296, manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152.   The instrument is designed for the rapid detection of bacteria and fungi in clinical specimens. Samples are drawn from patients and injected directly into BACTEC culture vials, which are placed into the instrument for incubation and testing.
no specific code provided; recall applies to all product in commerce
Undeclared allergens.  The product label does not declare allergens of Wheat Flour, Soy Flour, Whey, and Milk.
Worldwide Distribution. - US (Nationwide) and Mexico; and  Internationally to: Australia, Belgium, Canada, China, Columbia, Czech Republic, England, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Korea, Malaysia, Luxembourg, Netherlands, Poland, Russia, Saudia Arabia, Spain, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Venezuela, Vietnam
Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale, CA.    Indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy.
Potential Safety issue with Synchrony Boom Arm Mounting Assembly - one complaint of mounting assembly detaching.
Marquez Produce is recalling Fresh Cactus because of unapproved pesticides.
Cactus Leaves/pads (''Nopales''), 40 lbs
Marquez Produce is recalling cactus leaves due to unapproved pesticides.
Cactus Pads (Nopal) Mexpogroup:  Product of Mexico
Unapproved pesticides were found by the CA Department of Pesticide Regulation during sampling,
Atlantis PV, 8.5F,  15 MHz Peripheral Imaging Catheter: Sterile, R; Sterilized using irradiation.          Product Usage:  This catheter is a 15 MHz ultrasound imaging catheter intended to operate with an IVUS instrument for diagnostic imaging. It is used with an 8.5F-introducer sheath and a 0.035 guidewire.
Reports of physicians experiencing inability to pass a 0.035'' guidewire through the guidewire lumen and exit port at the (proximal) Y-manifold of the imaging catheter.
Monarch Breakfast Syrup, in 1.5 oz. portion control cups, Distributed by US Foods, Inc., Rosemont, IL 60018.
Worldwide Distribution: US (nationwide) including states of: FL, IN, NY, OR and PA; and internationally to: Australia and Israel.
Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips Healthcare, Cleveland, OH    The Brilliance iCT and iCT SP are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
Patient images exhibited ring artifacts.
Worldwide Distribution - US (Nationwide) and Internationally to: Austria, France, Germany The Netherland, Spain, Sweden, and Switzerland.
InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V).   Product Usage:  The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever reduction.      K080908
Phillips Healthcare initiated this action because the Main Control Board (MCB) may produce an inaccurate low patient temperature reading and low temperature alarm.
NatureBox Picante Ranch Mix Spicy Snack Mix with Corn Nuts and Masa Chips;    Net. WT: 4 oz. (113 g), Stand up Pouch,  Vegan  Ingredients: Corn Nuts (corn, canola oil, soybean oil, salt), Sugar, Flax Chips (Yellow corn masa, flax seeds, soybean oil, salt) Snack Seasoning(sour cream, salt, whey, corn syrup, tomato, maltodextrin, garlic powder, onion powder, cheddar cheese ([pasteurized milk, cheese cultures, salt, enzymes], whey, buttermilk solids, salt, disodium phosphate), milk, vinegar, soybean oil, citric acid, spice, parsley), corn Syrup, chili Powder, Red Pepper.  No UPC on product.    Distributed by NatureBox,  San Carlos, CA  94070
all lot codes with expiration date of 4/1/14 (includes consumer facing lot codes 3BC13324, 4BC13339, 5BC13340, 5BC13354, 5BC14003, 4BC13009). Supplier lot code 13274.
It was discovered that the specification used by the supplier was incorrect and therefore the ingredient statement was incorrect and did not include unbleached wheat flour and bulgur wheat. The packaging does note that the products are packaged in a facility that also processes tree nuts, peanuts, milk, wheat, egg and soy.
NatureBox Salsa Spiced Nut Mix; Net. WT: 4 oz. (113 g), Stand up Pouch,  Vegan  Ingredients: Almonds, Corn chips with flax (yellow corn masa, flax seed, soybean oil, salt), Cashews, seasoning ( tomato powder, salt, sugar, onion powder, garlic powder, spices, cilantro, lime juice powder, corn syrup, lime juice, lime oil, paprika, soybean oil), corn syrup, sugar.  No UPC on product.    Distributed by NatureBox,  San Carlos, CA  94070
Worldwide Distribution - US Nationwide in the states of CA, CO, FL, NV, NJ, PA, TX and the countries of CZECH REPUBLIC, FRANCE, JAPAN, REPUBLIC OF KOREA, SAUDI ARABIA, and TURKEY.
GE Healthcare Innova IGS 630. Biplane Cardiovascular and Interventional Imaging System.   Product Usage:  The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. The OR table is suitable for interventional and surgical procedures. The Cathiab Frontiers solutions are indicated for use in conjunction with single plane and biplane GE angiographic X-ray systems and imaging / data medical devices used in interventional and surgical cathlab environments and cleared for commercial distribution. The Cathiab Frontiers solutions are integrated GE angiographic X-ray and imaging / data medical devices that simplify the end-to-end clinical workflow in the cathlab by implementing: 1) Communication protocols for exchanging and automatically synchronizing patient, exam, system, and image information between the angiographic X-ray systems and the imaging / data medical devices. 2) Communication protocols for the control of imaging / data medical device functions from the angiographic X-ray systems user interface. 3) Interfaces for displaying the imaging / data medical device output on the monitor display solutions of the GE angiographic X-ray systems.
GE Healthcare has recently become aware of a potential safety issue with respect to IGS 630 Imaging Systems. While performing fluoroscopy on a biplane fluoroscopy unit, there is a potential for loss of the x-ray imaging function when the user changes the size of the lateral FOV (Field of View) and releases the biplane footswitch pedal simultaneously. This could lead to a system lock up requiring a restart of the system in order to recover its operations.  No injury has been reported due to this issue.