All sterile drugs compounded between 2/21/14 and 2/24/14.
Expiration dates between 3/5/14 and 3/10/14.
Lack of Assurance of Sterility: All compounded products.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL), 100 mL single-use bag packaged in a foil overwrap, Rx only, Sterile, For Intravenous Infusion, Mfd. for Sagent Pharmaceuticals Schaumburg, IL ---- NDC 25021-830-82
NDC 25021-830-82; Lot Numbers and Expiration Dates: Lot 30076, Expires 01/2015; Lot 30077, Expires 01/2015.
Lack of Assurance of Sterility; leaking of premix bags
Worldwide Distribution:US (Nationwide) including states of: AZ, CA, FL, IL, KY, MD, MN, MT, OH, PA, TN, TX, VA, WA, WI; and countries of: Belgium, China, and Saudi Arabia.
Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP Test Cartridges; are qualitative multiplexed in vitro diagnostic tests for simultaneous detection and identification of selected gram-positive (BC-GP) and gram-negative (BC-GN) bacteria and resistance markers.
There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence of Process SP Processing Error when used due to the Processor SP experiencing difficulty releasing the Tip to the final location in the Tip Assembly. The difficult releasing the Tip can result in a Processing Error and occasionally the Tip to be dropped into the Processor SP.
Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Cartridges; are qualitative multiplexed in vitro diagnostic tests for simultaneous detection and identification of selected gram-positive (BC-GP) and gram-negative (BC-GN) bacteria and resistance markers.
To retailers in MD, TX, FL, PA, IL, NJ, IN, LA, WA, ME, SC
Black Ant, 2800 mg, four capsules per box, Manufacturer Qinghai Baojiantang Pharmaceutical Co., Ltd.
Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil.
MOJO RISEN, 650 mg, 2 capsule per pouch, Distributed by: Mojo Risen, LLC, Springville, UT 84663
AFRICAN BLACK ANT, 2800 mg, 6 capsules per box, produced by: Qinghan Hongwei Bioengineering Company, No. 158, Renmin Road, Xining City.
CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50
Blade can shift during shipping which makes the product ineffective.
Product was distributed in ME, NH, and MA.
BAR HARBOR JAM COMPANY Maine Wild Blueberry Pancake Mix; Net Wt. 1 lb 6 oz (624 g)
BAR HARBOR JAM COMPANY Maine Wild Blueberry Muffin Mix; Net Wt. 1 lb 6 oz (624 g)
BAR HARBOR JAM COMPANY Maine Old Fashioned Popover Mix; Net Wt 1 lb 5 oz (624g)
Marcaine (bupivacaine HCl) injection, USP, 0.5%, Preservative-Free, 30 mL (150 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045  NDC 0409-1560-29
Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.
US: Nationwide in the states of:  (AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY)
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use.    The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.
1) Instrumed Item No.: 250-08800; Adler Instrument Company Catalog Code: 70-0300; Lot Number: 070113;  2) Instrumed Item No.: 250-08860 ; Adler Instrument Company Catalog Code: 70-0319; Lot Number: 030312, 070411;   3) Instrumed Item No.: 250-08930; Adler Instrument Company Catalog Code: 70-0318; Lot Number: 010113, 020113, 030112, 050412, 060413, 070512, 090213, 100113, 100411;   4) Instrumed Item No.: 250-08960 ; Adler Instrument Company Catalog Code: AD98-1008; Lot Number: 090310;   5) Instrumed Item No.: 250-09010 ; Adler Instrument Company Catalog Code: 70-0317; Lot Number: 100211
Additional caution statements have been added to the Instruction For Use for monopolar electrodes. The additional caution statements are as follows: 1) &quot;To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes.&quot; and 2) &quot;For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years.&quot;
Nationwide Distribution in the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
1) Instrumed Item No.: 250-08930; Ambler Surgical Corporation Catalog Code: J647-6; Lot Number: 060412;
1) Instrumed Item No.: 250-08680; Boss Instruments Catalog Code: 35-8015; Lot Number: 030411, 100110, 110210;  2) Instrumed Item No.: 250-08700; Boss Instruments Catalog Code: 35-8016; Lot Number: 030111;   3) Instrumed Item No.: 250-08700; Boss Instruments Catalog Code: 35-8016; Lot Number: 30111;   4) Instrumed Item No.: 250-08760; Boss Instruments Catalog Code: 35-8020; Lot Number: 020411, 070111, 100412, 110412;   5) Instrumed Item No.: 250-08770; Boss Instruments Catalog Code: 35-8020L; Lot Number: 020112, 110211, 120310;   6) Instrumed Item No.: 250-08800; Boss Instruments Catalog Code: 35-8025; Lot Number: 060110, 100112;   7) Instrumed Item No.: 250-08820; Boss Instruments Catalog Code: 35-8026  ; Lot Number: 032811;   8) Instrumed Item No.: 250-08860; Boss Instruments Catalog Code: 35-8030; Lot Number: 050413, 070412, 110510, 090110;   9) Instrumed Item No.: 250-08880; Boss Instruments Catalog Code: 35-8030L; Lot Number: 090110;   10) Instrumed Item No.: 250-08890; Boss Instruments Catalog Code: 35-8035; Lot Number: 100213;   11) Instrumed Item No.: 250-08930; Boss Instruments Catalog Code: 35-8040; Lot Number: 010211, 020213, 020811, 021711, 040212, 040311, 080212, 100310, 110113, 120413;   12) Instrumed Item No.: 250-08960; Boss Instruments Catalog Code: 35-8040L; Lot Number: 030413, 040412, 040513, 120113;   13) Instrumed Item No.: 250-08990; Boss Instruments Catalog Code: 35-8042; Lot Number: 050312;   14) Instrumed Item No.: 250-09000; Boss Instruments Catalog Code: 35-8042L; Lot Number: 100406;   15) Instrumed Item No.: 250-09010; Boss Instruments Catalog Code: 35-8045; Lot Number: 010311, 020311, 090312, 100212, 120112, 120213
1) Instrumed Item No.: 250-08570; CareFusion Catalog Code: VM46-9112-1; Lot Number: 010111;  2) Instrumed Item No.: 250-08600; CareFusion Catalog Code: LA8523  ; Lot Number: 070211, 070213, 090412;   3) Instrumed Item No.: 250-08610; CareFusion Catalog Code: LA8523-45; Lot Number: 042011, 062209;   4) Instrumed Item No.: 250-08620; CareFusion Catalog Code: LA8515; Lot Number: 030511, 040310, 080111;   5) Instrumed Item No.: 250-08630; CareFusion Catalog Code: LA8515-45; Lot Number: 050212;   6) Instrumed Item No.: 250-08660; CareFusion Catalog Code: LA8514; Lot Number: 040110;   7) Instrumed Item No.: 250-08670; CareFusion Catalog Code: LA8514-45; Lot Number: 120410;   8) Instrumed Item No.: 250-08680; CareFusion Catalog Code: LA8526; Lot Number: 010313, 060311, 060312;   9) Instrumed Item No.: 250-08690; CareFusion Catalog Code: LA8526-45; Lot Number: 030314, 100410, 120110, 120312;   10) Instrumed Item No.: 250-08700; CareFusion Catalog Code: LA8518; Lot Number: 060111, 070110, 080211;   11) Instrumed Item No.: 250-08710; CareFusion Catalog Code: LA8518-45; Lot Number: 010114, 040113, 040313, 060410;   12) Instrumed Item No.: 250-08730; CareFusion Catalog Code: LA8520-45; Lot Number: 010213;   13) Instrumed Item No.: 250-08740; CareFusion Catalog Code: LA8519; Lot Number: 060108, 080310;   14) Instrumed Item No.: 250-08760; CareFusion Catalog Code: LA8521; Lot Number: 020212, 060113, 060213, 100513, 121410;   15) Instrumed Item No.: 250-08770; CareFusion Catalog Code: LA8521-45; Lot Number: 100210;   16) Instrumed Item No.: 250-08780; CareFusion Catalog Code: LA8513; Lot Number: 010110, 050313, 070112, 122110;   17) Instrumed Item No.: 250-08790; CareFusion Catalog Code: LA8513-45; Lot Number: 090411, 100309, 100312;   18) Instrumed Item No.: 250-08800; CareFusion Catalog Code: LA8525; Lot Number: 040114, 090410, 110310, 120111;   19) Instrumed Item No.: 250-08810; CareFusion Catalog Code: LA8525-45; Lot Number: 050308, 060310;   20) Instrumed Item No.: 250-08820; CareFusion Catalog Code: LA8517; Lot Number:
1) Instrumed Item No.: 250-08930; Pilling Weck Inc. / Teleflex Medical Catalog Code: 728163; Lot Number: 66745
1) Instrumed Item No.: 250-08930; Specialty Care Catalog Code: 30-92221; Lot Number: 040413
1) Instrumed Item No.: 250-08860; Symmetry Surgical Inc. Catalog Code: 90-9525; Lot Number: 030214;  2) Instrumed Item No.: 250-08930; Symmetry Surgical Inc. Catalog Code: 90-9522; Lot Number: 070511;   3) Instrumed Item No.: 250-08990; Symmetry Surgical Inc. Catalog Code: 90-9526; Lot Number: 031511;   4) Instrumed Item No.: 250-09010; Symmetry Surgical Inc. Catalog Code: 90-9523; Lot Number: 080112
1) Instrumed Item No.: 250-09010; Phoenix Instruments Catalog Code: 190-9523; Lot Number: 070411;  2) Instrumed Item No.: 250-09040; Phoenix Instruments Catalog Code: 190-9527; Lot Numbers: 010211, 040411
1) Instrumed Item No.: 250-08930; Surgical Direct Catalog Code: SD175200.100; Lot Number: 070512;  2) Instrumed Item No.: 250-08700; Surgical Direct Catalog Code: SD11451.140; Lot Number: 080211;   3) Instrumed Item No.: 250-08930; Surgical Direct Catalog Code: SD175200.100; Lot Numbers: 030112, 080212, 010113, 020113;   4) Instrumed Item No.: 250-08960; Surgical Direct Catalog Code: SD17520045.100; Lot Number: 070412;   5) Instrumed Item No.: 250-089360; Surgical Direct Catalog Code: SD175200.100; Lot Number: 030413
1) Instrumed Item No.: 250-08660; Surgimed - MLB Catalog Code: 91-112; Lot Numbers: 040110, 100112
Worldwide Distribution - USA including AL, AK, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WAM WI, WY, District of Columbia,  Puerto Rico and Internationally to Algeria, Argentina ,  Australia ,  Austria ,  Bangladesh ,  Belgium ,  Brazil ,  Bulgaria ,  Canada ,  Chile ,  China,   Colombia ,  Croatia ,  Czech Republic ,  Denmark ,  Ecuador ,  Egypt ,  Finland ,  France ,  Germany ,  Hong Kong ,  Hungary ,  India ,  Indonesia ,  Iran ,  Ireland ,  Israel ,  Italy ,  Japan ,  Kazakhstan ,  Korea,   Kuwait ,  Latvia ,  Libya ,  Lithuania ,  Malaysia ,  Mexico ,  Morocco ,  Myanmar ,  Netherlands ,  New Zealand ,  Norway ,  Oman ,  Pakistan ,  Peru ,  Philippines ,  Poland ,  Portugal ,  Qatar ,  Romania ,  Russia,  Saudi Arabia ,  Singapore ,  Slovakia ,  Slovenia ,  South Africa ,  Spain ,  Sweden ,  Switzerland ,  Taiwan ,  Thailand ,  Tunisia ,  Turkey ,  United Arab Emirates ,  Ukraine ,  United Kingdom ,  Vietnam
The Symbia T Series consists of the T16, T6, T2, and T. The Symbia T integrates state-of-the-art SPECT and high quality spiral CT to provide precise attenuation correction and anatomical mapping. The system can also be used as a complete clinical SPECT system for general purpose, WB and SPECT applications.  The Symbia T integrates state-of-the-art SPECT and high quality spiral CT to give the system SPECT functionality, with attenuation correction.   The Symbia T2 integrates state-of-the-art SPECT and high quality dual slice spiral CT to give the system full functionality for all SPECT-only, SPECT-CT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology.   The Symbia T6 integrates state-of-the-art SPECT and high quality six slice spiral CT to give the system full functionality for all SPECT-only, SPECT-CT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology.   The Symbia T16 integrates state-of-the-art SPECT and high quality sixteen slice spiral CT to give the system full functionality for all SPECT-only, SPECT-CT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology.   For the Symbia T16/T6/T2, the ultra fast multi-slice spiral CT maximizes confidence in diagnostic stand-alone CT, as well as precise attenuation correction and anatomical mapping. Acquisitions can be performed with either the CT preceding the nuclear acquisition or vice versa.  Indications for use: SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. CT: The CT component is intended to produce cross sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial place taken at different angles or spiral planes taken at different angles. SPECT+CT: Perform CT scans and nuclear imaging studies within the same instrument. To obtain attenuation corrected images and t
Siemens Medical Solutions USA, Inc. is performing a field correction because we recently detected a rubber isolator with unfavorable aging properties. The function of the rubber isolator, which is situated within the rotate motor mounting assembly, may degrade over time and may impact motor support. The event does not pose a hazard by itself but could lead to a rupture of the drive belt which in turn could damage the gantry covers and make contact with the patient.
The Symbia Intevo series consists of the Intevo 16, Intevo 6 and Intevo 2. This manual also describes the Symbia Intevo Excel. The Symbia Intevo series integrates state-of-the-art SPECT and high quality spiral CT to provide precise attenuation correction and anatomical mapping. The system can also be used as a complete clinical SPECT system for general purpose, whole body (WB) and SPECT applications.  The Symbia Intevo Excel integrates state-of-the-art SPECT and high quality spiral CT to give the system SPECT functionality, with attenuation correction.   The Symbia Intevo 2 integrates state-of-the-art SPECT and high quality dual slice spiral CT to give the system full functionality for all SPECT-only, xSPECT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology.   The Symbia Intevo 6 integrates state-of-the-art SPECT and high quality six slice spiral CT to give the system full functionality for all SPECT-only, xSPECT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology.   The Symbia Intevo 16 integrates state-of-the-art SPECT and high quality sixteen slice spiral CT to give the system full functionality for all SPECT-only, xSPECT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology.  Indications for use: SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. CT: The CT component is intended to produce cross sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial place taken at different angles or spiral planes taken at different angles. SPECT+CT: Perform CT scans and nuclear imaging studies within the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy.
Domestic to Puerto Rico and  USA (NY,MA,NJ,TX,IL,FL,GA,CA,VA) and Internationally (Aruba, Curacao,Virgen Gorda, Angilla, Antilles, Saint Barts, Dominica, St.Vincent, Barbados, Saint Marteen, Saint Thomas, Monserrat, Grenada, Antigua, Tortolo, Nevis, St. Kitts, Nevis, St. Jonhs, and St. Croix)
Goya Black Beans  Frijoles Negros 15.5 oz (439g)
Goya de Puerto Rico is recalling the following products due to a possible can seam defect that may compromise the integrity of the product.
Goya Whole Green Peas Chicharos 15.5 oz (439g)
Pink Beans sold under two brand names Goya and Jibarito (see labels description below)   Goya Pink Beans Habichuelas Rosadas 15.5 oz. (439g)    El Jibarito Habichuelas Rosadas 15.5 oz. (439g)
Goya Chick Peas Garbanzos 15.5 oz. (439g)
Goya Red Kidney Beans  Habichuelas Coloradas 15.5 oz. (439 g)
Goya Pinto Beans Habichuelas Pintas 15.5 oz. (439g)
Goya  Pink Beans  In sauce prepared with Olive Oil, Cilantro & Onion 15 oz. (425g)
Goya Black Bean Soup Prepared with  Olive Oil, Bell Pepper & Onion 15 oz. (425g)
Goya Pinto Beans In Sauce prepared with Olive Oil, Cilantro &Tomato 15 oz. (425g)
Goya Small Red Beans  Habichuelas Coloradas Pequenas 15.5 OZ (439g)
CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufactured for: Cubist Pharmaceuticals, Inc., Lexington, MA 02421, NDC 67919-011-01, UPC 3 67919-011-01 6.
Presence of Particulate Matter: Potential presence of glass particulate matter in the vials.
ReBalance Antiprotozoal Oral Suspension (Sulfadiazine and Pyrimethamine For Oral Use in Horses Only
Low assay result for the Pyrimethamine at the 6-month stability time point.
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL Ambu-Flex II container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL  60015; Product Code L5B5202, NDC 0941-0457-05.
Presence of Particulate Matter: particulate matter was found during the manufacturing process.
Platelets Pheresis Leukocytes Reduced Irradiated
Plateletpheresis product, lacking product quality control, was distributed.
ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500.      Intended Use of the Product: Envoy 500 AST Reagent is for the quantitative in vitro diagnostic determination of aspartate aminotransferase (AST) in human serum and plasma using the Envoy 500 Chemistry System.    Aspartate aminotransferase (AST) measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.
Lot 4014, Expiration date 07/2015; Lot 4051, Expiration date 09/2015;  Lot 4074, Expiration date 11/2015;
Some users of ENVOY 500 AST Reagent Kit, reference 55255, for Envoy 500 systems are observing that Quality Control (QC) fails before the product expiry is reached.
Distributed in the states of Texas and Illinois.
Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead).   Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.
The Directions for Use (DFU) manual contains information for devices that are not approved in the US.  The correct US approved versions of the manuals were sent to the customers to replace the incorrect international manuals.
Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead).   Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.
Distribution was made to AL, AK, AR, AZ, CA, CO, DE, IA, IL, IN, FL, GA, KS, KY, MA, MD, ME, MI, MO, MN, NC, NE, NH, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.  Foreign distribution was made to Canada and Australia.
Glow OLOGY Renew body butter packaged in 226 g (8 oz.) jars. Made in the USA. Distributed by DD Traders Inc. dba DEMDACO, Leawood, Kansas 66209. glowologyskincare.com
The product is contaminated with Pseudomonas luteola.
Nationwide Distribution including the states of : HI, CA, UT, NY, OH, IN, AL, FL, GA, WI, IA, MN, NE, SD, NJ, PA, ND, IL, MO, VA, MD, NC, MI, OR, WA, KS, KY, TN, WV, OK, CT, MA, ME, AZ, NM, TX, LA, ID, CO, MT, UT, NV and AK., and Internationally to Singapore, Japan, Germany and Canada.
Persona The Personalized Knee System 2.5 mm Female Screw 48 mm Length Sterile Qty-2, Sterilized using irradiation, single use.
The Persona 48mm X 2.5mm Female Screw is being recalled due to potential use of the screw in cortical bone, and corresponding stripping of the 2.5mm Persona Hex Driver.
Source plasma product, for which donor eligibility was not complete, was distributed.
US Nationwide Distribution in the states of FL, GA, MS, TN and CO.
The Rejuvenator Chamber manufactured by Baro-Therapies, Inc.   Product  Usage:  Indicated for relief from general aches and pains brought on by changes in the weather.
The firm is distributing the Rejuvenator device without an approved 510(k).
Avera McKennan Hospital & University Health Center
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt- Jacob Disease (vCJD), were distributed.
Worldwide Distribution - USA (Nationwide) and Internationally to Australia Austria  Belgium  Canada  Czech Republic  Finland  France  Germany  Great Britain  Italy  Japan  Netherlands  New Zealand  Norway  Portugal  Slovak Republic  Slovenia  South Korea  Spain  Switzerland
Siemens Dimension Vista CHEM 1 CAL, lot 3GM081.   The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyroxine Uptake (TU), Blood Urea Nitrogen (BUN), and Uric Acid (UA) methods on the Dimension Vista System.
Siemens Healthcare Diagnostics has received complaints for low recovery of Magnesium (MG) Quality Control (QC) and patient samples following calibration of MG with the Dimension Vista&reg; CHEM 1 CAL, lot 3GM081.   Investigation by Siemens confirms that QC and patient samples under-recovers MG by 0.25 mg/dL [0.10 mmol/L] across the assay range following calibration with 3GM081.
Worldwide Distribution - US Nationwide and the countries of Europe, Canada, Australia, China, Russia, Taiwan, Singapore, and Thailand.
eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm  & Tubehead, 765DC    Product Usage:  intraoral x-ray
Models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm  & Tubehead, 765DC; with multiple part numbers and serial numbers: see distribution list for these details.
Two (2) failures of the spring link components within the articulated arm assembly. The spring links broke during normal assembly process for the articulated arm during first cycle of the arm, prior to the 14lb tube head (full load) being installed onto the assembled articulated arm.
Worldwide Distribution including the United States., and the countries of  Argentina, Austria, Australia, Bahrain, Bangladesh, Belgium, Belgrade, Brazil, Botswana, Canada, Chile, China, Colombia, Croatia, Czech Republic, Cyprus, Denmark, Egypt, Estonia, Finland, France, Germany, Georgia, Great Britain, Hungary, Indonesia, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Kazakhstan, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Myanmar, New Caledonia, Netherlands, Norway, New Zealand, Pakistan, French Polynesia, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, Slovakia, South Africa, Spain, Switzerland, Thailand, Turkey, United Arab Emirates, Vatican, Venezuela, Vietnam, Yemen and Zimbabwe.
ADVIA Centaur Immunoassay System (including refurbished units),    This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.
Domestic: 2771 units; Foreign: 7744 units
The firm has identified an issue with patient demographic information sent to the LIS from the ADVIA Centaur/ADVIA Centaur XP Immunoassay systems.  Siemens has confirmed that under extremely rare circumstances patient demographic data from the previous order received from the LIS is merged with the next order.  This issue can occur when the LIS data buffer on the ADVIA Centaur system becomes full and a particular character is found in the last five locations in the LIS data buffer.  In this case, the incorrect patient demographic information will be transmitted to the LIS and will be displayed on the ADVIA Centaur user interface and instrument generated printed reports.
ADVIA Centaur XP Immunoassay System (including refurbished units),    This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.
Worldwide Distribution: US (nationwide) and in the country of: Singapore.
VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD.   For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Domestic: 339 sales units; Foreign: 10 sales units
Ortho Clinical Diagnostics identified a potential for biased results to be generated when using VITROS PHYT Slides, Lot 2613-0150-4913.  Some positively biased results were identified during testing of a different VITROS PHYT Slide lot; the affected slides were not released for distribution.  Since Lot 2613-0150-4913 was manufactured in the same event, there is the potential for slides from this lot to also be affected.
Worldwide Distribution -- USA and Canada.
SPECTRUM Pump, Model No. 35700BAX.    Intended to be used for the controlled administration of intravenous fluids.
One Service Technician may not have correctly serviced specific Sigma Spectrum Infusion Pumps according to established procedures during the time period of 5/5/2014 through 6/3/2014.
Distributed in the states of California, Delaware, Indiana, Missouri, New Jersey, New York, and Oregon.
LAP-BAND AP SYSTEM AP Large with Access Port, Allergan, LAP-BAND AP SYSTEM Access Port I.  Product was distributed for both the AP Large and AP Standard sizes.   The LAP-BAND System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity related comorbid conditions.
Product was distributed past its expiration date.
Worldwide Distribution - USA (nationwide) and Internationally to JAPAN, CHINA, and CANADA.
Array LaserLink, Manufactured by Lumenis,   The Array'' LaserLink'' is a laser system accessory intended for use in the treatment of ocular pathology. '' For the Posterior Segment, the Array'' LaserLink'' is indicated for use in Retinal Photocoagulation and Panretinal Photocoagulation of Vascular and Structural Abnormalities of the Retina and Choroid including: '' Proliferative and Severe and Very Severe Non-Proliferative Diabetic Retinopathy '' Macular Edema associated with Proliferative or Non-Proliferative Diabetic Retinopathy '' Choroidal Neovascularization '' Retinal Neovascularization associated with Retinal Occlusive Disease (Branch Retinal Vein Occlusion; Central Retinal Vein Occlusion) '' Macular Edema associated with Branch Retinal Vein Occlusion '' Retinal Tears and Detachments And Anterior Segments as follows: '' Iridotomy in Closed Angle Glaucoma '' Trabeculoplasty in Open Angle Glaucoma
All assembled units since product release, Part Number: GA-0006700.
Lumenis initiated a field-correction for the Array Laser Link&quot;, GA-0006700 (SN XXYYZZ) because the system may project an erroneous pattern display on the retina, which is different than the desired pattern.
Basil Pesto Pasta packaged in a non-flex plastic tub, net wt 8 oz.  A green sticker is placed on the lid of the package which contains the lot code.  Product is refrigerated
0825, 0826, 0827, and 0828.   Code represents month (08) and day (25) of expiration
Tj's Place is recalling Basil Pesto Pasta packed in 8 oz. plastic tubs because it has the potential to be contaminated with Listeria monocytogenes.
Ivermax (Ivermectin) 1% sterile solution is provided in a 500 mL plastic bottle suitable for use with automatic syringe equipment. Each bottle contains sufficient solution to treat 100 head of 550 lb (250 kg) cattle or 1000 head of 38 lb (17.3 kg) swine.
This recall has been initiated due to incorrect information printed on the bottle carton.  Specifically the carton indicates that the manufacturing date was May 2014 where as the correct information (as indicated on the bottle) is that the expiry date is May 2014.  There is a chance that customers may use the product after the expiration date based on the carton label.  The bottle inside the carton is correctly labeled as ''EXP MAY 2014''.
Worldwide Distribution: US distribution in state of: CA and countries of: Poland, Singapore, and Sweden.
Philips Expression MR200 MRI Patient Monitoring System Model 866120
During production, excess metal (aluminum) debris was found stuck to the cling plastic that covers the device's pole assembly. The metallic debris could affect system performance due to the potential for a failure to power up or loss of power. This could result in the loss of monitoring and a delay in diagnosis of the patient.
Worldwide Distribution - US Nationwide in the states of AZ, CA, FL, IL, KY, OH, NJ, NY, TX, LA, OR, SD, WA, including  Puerto Rico, and the countries of Belgium, Canada, Chile, China, Colombia, Korea, Mexico, Peru, Venezuela and Zaire.
Hudson RCI Pediatric Anesthesia Breathing Circuits, Single Patient Use,  Rx Only,    Product Usage:  To administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Ypiece.
The pediatric breathing circuits can crack prior to and during use.
Worldwide Distribution - US nationwide and the countries of:  Belgium, Germany, China(Hong Kong), India, Israel, Italy, and the United Kingdom.
ASSEMBLY, PATIENT SIDE CART, PS4000 used with the da Vinci Xi Surgical System.   Product Usage:  The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
Correction due to the detection of a motor sensor failure in the Patient Cart instrument arms of the da Vinci Xi (IS4000) Surgical Systems after a mid-procedure restart.
Worldwide Distribution - US including the states of : AZ, CA, CT, FL, GA,MA, MS,OH, PA, TX, and WY., and the countries of : Australia, Denmark, Finland, France, Germany, India, Ireland, Japan, Malaysia, Netherlands, New Zealand, Norway, Russia, Slovakia, South Africa, South Korea, Sweden, Switzerland and United Kingdom.
The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners 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. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories
Ingenuity CT system can mislabel the exposure that results in an image in the incorrect order that it was taken by the user.
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60, UPC 3 05910 39860 6.
Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0397-60, UPC 3 05910 39760 9.
Nationwide Distribution - US including UT, MO, CO, MA, MN, MS, OH, SC, MI, and NY.
Siemens Ysio Max system The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio Max system is not meant for mammography. The Ysio Max uses integrated or portable digital detectors for generating diagnostic images by converting x-rays into electronic signals. Ysio Max is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max systems with a specific set of serial numbers that will cause lost images due to an automatic Radiology Information System (RIS) worklist update, thus causing examinations to be repeated. Image label may also be displayed incorrectly after images have been sent to PACS or hardcopy/filming, thus leading to potentially incorrect diagnosis.
Siemens  AXIOM Luminos dRF Max systems  The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image.
Siemens AXIOM Luminos dRF Max system material #s: 10762471 with serial number: 5037.
Siemens Uroskop Omnia Max system  The Uroskop Omnia is a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic, endourology and minimal invasive urology/surgery). The system,, which includes a radiologic/urologic treatment table, may be used for urological, gastroenterological and gynecological treatment, planning and diagnostic procedures including but not limited to: ''Querying and retrieving patient history information and/or previous diagnosis and images from other modalities; ''X-ray examinations of the urogenital area ''Ultrasound examinations ''Endourological interventions ''Percutaneous interventions ''Laparoscopy ''Application of fistula ''Simple procedures ''Extracorporeal shock wave lithotripsy ''Uroflow/urodynamics ''Pediatric radiological and therapeutic applications
Siemens  Uroskop Omnia Max system, material #s: 10762473, serial numbers: 4014 4015
Siemens Luminos Agile Max system  The Luminos Agile is intended to be used as a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. Luminos Agile is applicable to emergency treatment on an outpatient basis, as well as for bedside examinations.
Siemens Luminos Agile Max system material #s: 10762472, with serial numbers: 61013 61015  61011  61014  61017
2/24 ounce clear plastic bags of 3/8 inch diced Roma tomatoes.  These bags are in a cardboard carton.  The bags and carton have a yellow label that reads in part: Boskovich Farms, Inc Costco Deli Dept. 63 ***QUINOA SALAD KIT Item # 624843 CONTENTS: (2) QUINIA MIX *** (2) Diced Roma ***  NET WT: 23.96 LBS.
Boskovich Farms is recalling Roma Tomatoes because they may be contaminated with Salmonella.
2-5 lb. clear plastic overwrapped black poly trays of 3/8'' diced Roma Tomato per cardboard carton.  Cardboard carton labeled: 2-5 LB. DICED TOMATOES 3/8  PACKED BY BOSKOVICH FARMS OXNARD CA, 93030 PRODUCT OF MEXICO.
CREON (pancrelipase) Delayed-Release Capsules, Lipase 24,000 USP Units, 250 Capsule Bottles, Rx Only. Marketed by: AbbVie Inc., North Chicago, IL 60064, Product of Germany. NDC 0032-1224-07.
Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.
DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only,  Baxter USA, NDC 0338-1005-02.
Lack of Assurance of Sterility: A small cut in the solution bag may have been introduced during the manufacturing process, resulting in a leak of the bag into the overpouch.
Worldwide Distribution - US Nationwide - AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS,KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OR, PA, SC, TN, TX, UT, VA, WA, WV, WI and in the countries CANADA, GERMANY, UNITED KINGDOM.
GE Healthcare Precision 500D, Classical R&F System.   Product Usage:  The Precision 500D R&#38;F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&#38;F and Pediatric examinations.
GE Healthcare has become aware of a potential safety issue involving missing screws used for mounting the overhead Video Monitor to the tray assembly on a single monitor suspension. This issue affects the Precision 500D X-ray imaging systems.