Burn 7 Capsules, supplied in 30 capsules bottle
Marketed Without an Approved NDA/ANDA: Undeclared sibutramine and phenolphthalein  in Burn 7 dietary supplement
Worldwide Distribution - US Nationwide including District of Columbia and Puerto Rico; Algeria, Andorra, Angola, Argentina, Armenia, Austria, Azerbaijan, Bahamas, Bangladesh, Barbados, Belarus, Belgium, Bosnia & Herzegovina, Brazil, Brunei, Bulgaria, Cameroon, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, Gaza and Jericho, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, ITALY, Jamaica, Japan, Jordan, Kenya, Korea (South Korea), Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Mali, Mauritania, Mexico, Montenegro, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Panam, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, San Marino, Saudi, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, SPAIN, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, Ukraine, Uruguay, Venezuela, Vietnam, and Yemen
ARCHITECT Intact PTH Reagent Kit (8K25) consists of: 1 Bottle (6.6 mL) Anti-PTH (goat, polyclonal) coated microparticles in TRIS buffer with a preservative of sodium azide; 1 Bottle (5.9 mL) Anti-PTH (goat, polyclonal) acridinium-labeled conjugate in MES buffer with protein (bovine, goat) stabilizer with a preservative of sodium azide; and, 1 Bottle (10.0 mL) Intact PTH Assay Diluent containing phosphate buffer with protein (bovine, goat) stabilizer with a preservative of sodium azide.   Product Usage:  The ARCHITECT Intact PTH assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma on the ARCHITECT i System.
1) List Number 8K25-20; Lot Numbers and Expiration Dates: Lot 00913F000, Expires 23 NOV 2014; Lot 01313C000, Expires 21 AUG 2014; Lot 01512K000,  Expires 25 APR 2014; Lot 01712H000, Expires 23 FEB 2014; Lot 01813I000, Expires 13 MAR 2015; Lot 02213K000, Expires 08 MAY 2015; Lot 01312G000, Expires 13 JAN 2014; Lot 00512H000, Expires 13 JAN 2014.    2) List Number: 8K25-25; Lot Numbers and Expiration Dates: Lot 00112K000, Expires 25 APR 2014; Lot 01113C000, Expires 21 AUG 2014; Lot 01313G000, Expires 05 JAN 2015; Lot 01612H000, Expires 23 FEB 2014; Lot 01913I000, Expires 02 FEB 2015; Lot 02213D000, Expires 05 OCT 2014; Lot 00113K000, Expires 11 APR 2015; Lot 01212G000, Expires13 JAN 2014; Lot 00412H000, Expires 13 JAN 2014.     3) List Number: 8K25-27; Lot Numbers and Expiration Dates: Lot 00212K000, Expires 25 APR 2014; Lot 01213C000, Expires 21 AUG 2014; Lot 01413G000, Expires 05 JAN 2015; Lot 01812H000, Expires 23 FEB 2014; Lot 02013I000, Expires 02 FEB 2015; Lot 02313D000, Expires 05 OCT 2014; Lot 00213K000, Expires 11 APR 2015; Lot 01412G000, Expires 13 JAN 2014; Lot 00612H000, Expires 13 JAN 2014.
1) List Number 08K25-20: 6,433 assay kits; 2) List Number 08K25-25: 20,124 assay kits; 3) List Number 08K25-27: 10,968 assay kits
Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential to generate falsely elevated results on patient samples. Results generated with impacted lots may demonstrate a positive shift relative to those generated with previous reagent and/or calibrator lots. The issue may also impact your established ARCHITECT Intact PTH reference ranges. Abbott ARCHITECT Intact PTH Controls do not detect the shift. All current reagent, calibrator, and control inventory is impacted.
Worldwide Distribution -  US: Nationwide in the states of (AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY) + District of Columbia + Puerto Rico; *** FOREIGN: Algeria , Andorra ,  Angola ,  Argentina ,  Armenia ,  Austria ,  Azerbaijan ,  Bahamas ,  Bangladesh ,  Barbados ,  Belarus ,  Belgium ,  Bosnia & Herzegovina ,  Brazil ,  Brunei ,  Bulgaria ,  Cameroon ,  Canada ,  Cayman Islands ,  Chile ,  China ,  Columbia ,  Costa Rica ,  Croatia ,  Cyprus ,  Czech Republic ,  Denmark ,  Dominican Republic ,  Ecuador ,  Egypt ,  El Salvador ,  Ethiopia ,  Finland ,  France ,  Gaza & Jerichno ,  Georgia ,  Germany ,  Greece ,  Guatemala ,  Honduras ,  Hong Kong ,  Hungary ,  India ,  Indonesia ,  Iran ,  Iraq ,  Ireland ,  Israel ,  ITALY ,  Jamaica ,  Japan ,  Jordan ,  Kenya ,  Korea (South Korea) ,  Kuwait ,  Kyrgystan ,  Latvia ,  Lebanon ,  Libya ,  Lithuania ,  Luxembourg ,  Macedonia ,  Malaysia ,  Maldives ,  Mali ,  Mauritania ,  Mexico ,  Montenegro ,  Morocco ,  Netherlands ,  New Zealand ,  Norway ,  Oman ,  Pakistan ,  Palestine ,  Panama ,  Panam  ,  Paraguay ,  Peru ,  Phillipines ,  Poland ,  Portugal ,  Qatar ,  Romania ,  Russia ,  San Marino ,  Saudi ,  Senegal ,  Serbia ,  Singapore ,  Slovakia ,  Slovenia ,  South Africa ,  SPAIN ,  Sri Lanka ,  Sweden ,  Switzerland ,  Taiwan ,  Thailand ,  Trinidad & Tobago ,  Tunisia ,  Turkey ,  United Arab Emirates ,  United Kingdom ,  Ukraine ,  Uruguay ,  Venezuela ,  Vietnam ,  Yemen
ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibrator A contains Bis Tris Propane buffer with protein (bovine) stabilizer. Calibrators B-F contain PTH (synthetic peptide) in Bis Tris Propane buffer with protein (bovine) stabilizer. Preservatives: sodium azide and ProClin 300.   Product Usage:  The ARCHITECT Intact PTH assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma on the ARCHITECT i System.
List Number: 8K25-01. Lot Numbers and Expiration Dates: Lot 00613I000, Expires 05 SEP 2014; Lot 01913C000, Expires 14 MAR 2014; Lot 01913K000, Expires 12 NOV 2014; Lot 02413E000, Expires 09 MAY 2014; Lot 01312K000, Expires 12 NOV 2013;  Lot 00813A000, Expires 08 JAN 2014; Lot 01412H000, Expires 16 AUG 2013; Lot 00912F000, Expires 30 MAY 2013.
ARCHITECT Intact PTH Controls consists of 3 x 1 Bottle (8.0 mL each) of PTH (synthetic peptide) in Bis Tris Propane buffer with protein (bovine) stabilizer. Preservatives: sodium azide and ProClin 300.   Product Usage:  The ARCHITECT Intact PTH assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma on the ARCHITECT i System.
List Number: 8K25-10. Lot Numbers and Expiration Dates: Lot 00713I000, Expires 05 SEP 2014; Lot 01813C000, Expires 14 MAR 2014; Lot 01813K000, Expires 12 NOV 2014; Lot 02613E000, Expires 09 MAY 2014; Lot 01412K000, Expires 12 NOV 2013; Lot 00713A000, Expires 08 JAN 2014; Lot 01012F000, Expires 30 MAY 2013.
ParaGard T 380A - Intrauterine Copper Contraceptive, 176 mg of copper wire, Duramed Pharmaceuticals Inc, a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY
Non-sterility: due to a failed sterility test
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
The product was shipped to the following states: IN, KY, OH & WV.
Vitamin D Milk GRADE A PASTEURIZED HOMOGENIZED; 4-oz paper, 300-gal totes, Gallons, 1/2 gallons, pints, quarts, paper 1/2 pints, 5-gal dispense bags. INGREDIENTS: MILK AND VITAMIN D3.  Product is sold under the following brand names and UPC codes: American Fare: Gal: 0 72000 15233 1,  Gal: 0 72000 15238 6; Community Market: Gal: 0 70554 27197 9; Dairymens: Gal: 0 72804 00190 3,  Gal: 0 72804 00158 3 & Pint: 0 72804 00159 0; Friendly Farms: Gal: 0 41498 19215 0; Glenview Farms: Gal: 7 58108 22723 1, 1/2Pt: 7 58108 22724 8; IGA: Gal: 0 41270 02491 4 &  Gal: 0 41270 05844 5; Modern Foods: Gal: 0 80761 03000 3; Our Family: Gal: 0 70253 65100 7; UDF: Gal: 0 76310 05005 9,  Gal: 0 76310 05002 8, Qt: 0 76310 05300 5 & Pt: 0 76310 05250 3.
The firm was informed that the product has more than double the labeled amount of Vitamin D. The target minimum level is 400 IU per Qt. The product contains 1006 IU per Qt.
Worldwide Distribution-USA (nationwide) and the countries of  Afghanistan Algeria Armenia Austria Bahrain Belgium Bulgaria Burkina Faso Canary Islands Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Great Britain Greece Hungary Iceland Iran Iraq Ireland Israel Italy Jordan Kazakhstan Latvia Lebanon Lithuania Luxembourg Macedonia Malta Netherlands Norway Oman Pakistan Poland Portugal Qatar Romania Russian Fed. Saudi Arabia Serbia Slovakia Slovenia Spain Sweden Switzerland Turkey Unit.Arab Emir. Vatican Yemen.
ADVIA Centaur Systems TSH3 Ultra Ready Pack, 100 test Catalog Number:  06491072; Siemens Material Number: 10282378.    Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
Kit lots ending in/Exp Date: 266    17 April 2014  267    17 June 2014  269    01 August 2014  270    30 September 2014  271    18 November 2014  272    21 January 2015  273    18  November 2014
Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.
ADVIA Centaur Systems TSH3 Ultra , Ready Pack, 500 test Catalog Number: 06491080; Siemens Material Number: 10282379.    Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
Kit lots ending in/Exp Date: 266    17 April 2014  267    17 June 2014  269    01 August 2014  270    30 September 2014  271    18 November 2014  272    21 January 2015
ADVIA Centaur Systems TSH3 Ultra 2500 tests Catalog Number: 04862625; Siemens Material Number (SMN) : 10361944.    Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
ADVIA Centaur Systems VitD 100 test, Ready Pack, Catalog Number: 10491994.   Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
Kit lots ending in/Exp Date: 023   07 July 2014  024   08 September 2014  025   08 December 2014  026   09 February 2015  027  10 April 2015
ADVIA Centaur Systems VitD  500 test, Ready Pack,  Catalog Number: 10631021.    Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
Kit lots ending in/Exp Date: 023     07J uly 2014  024     08 September 2014  025     08 December 2014  026     09 February 2015  027    10 April 2015
ADVIA Centaur Systems VitD Total 100 test, Ready Pack,  For OUS; SMN 10699201.    Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
Kit lots ending in/Exp Date: 050     08 August 2014  051    20 September 2014  052    11 December 2014  053    10 December 2014  054     07 March 2015
ADVIA Centaur Systems BRAHMS PCT 100 test Sold only OUS; Catalog Number: 10378883.
Kit lots ending in/Exp Date: 020    11 July 2014  021    15 December 2014  022     24 February 2015  023     25 February 2015  024     03 July 2015
US Nationwide Distribution in the states of AL, ME, PA, IL, and CA.
Siemens Linear Accelerator (LINAC) models.    Product Usage:  deliver X-ray radiation for therapeutic treatment of cancer
Siemens Radiation Oncology became aware that customers may be using the Siemens Linear Accelerator in combination with stereotactic accessories which have not been validated as being compatible with Siemens LINAC models.
Worldwide Distribution-USA (nationwide) and the countries of  Canada, Albania, Lebanon, Austria, Libya, Bahrain, Lithuania, Bangladesh, Barcedonia, Belgium, Maldives, Bosnia/Herzegovina, Malta, Canary Islands, Morocco, Croatia, Namibia, Cyprus, Netherlands, Czech Republic, Niger, Denmark, Norway, Egypt, Oman, Faroe Islands, Pakistan, Finland, Poland, France, Portugal, Gabon, Qatar, Georgia, Reunion, Germany, Romania, Greece, Russian Federation, Hungary, San Marino, Iceland, Saudi Arabia, India, Serbia, Iran, Slovakia, Iraq, Slovenia, Ireland, South Africa, Israel, Spain, Italy, Sweden, Ivory Coast, Switzerland, Jordan, Tunisia, Kazakhstan, Turkey, Kenya, Turkmenistan, Kuwait, Ukraine, Latvia, UAE, UK, Zambia, Asia Pacific: Australia, Korea, Brunei, Malaysia, Cambodia, Myanmar, China, New Caledonia, French Polynesia, New Zealand, Hong Kong, Philippines, Indonesia, Singapore, Sri Lanka, Taiwan, Thailand, Japan, Latin America: Argentina, Curacao, Barbados, Ecuador, Bolivia, French Guiana, Brazil, Guatemala, Cayman Islands, Honduras, Chile, Mexico, Colombia, Panama, Costa Rica, Peru, Suriname, and Uruguay.
LIFEPAK 1000 defibrillator.   The LP1000 (in AED mode) is indicated for use on patients in cardiac arrest.
96,261 total; 40,818 within the US and 55,281 outside US.
Physio-Control has become aware of incidents where customers have attempted to use their LIFEPAK 1000 defibrillator and the device has shut down unexpectedly due to a very low battery.  A defibrillator in this scenario has the potential to fail to deliver a shock, with the potential result  that therapy is not delivered and a patient is not resuscitated.  A software malfunction in the LIFEPAK 1000 defibrillator causes the Readiness Display panel to incorrectly indicate a low battery charge when the battery is actually in a very low charged state and in need of replacing. Batteries that are at both low battery charge and very low battery charge must be replaced with a fully charged battery, whether or not  the ''OK'' symbol is present.
Nationwide (32 states): AK, AL, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, LA, MA, MD, MI, NC, NH, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI.  Products were also sent back to Advantage Health Matters, Markham, ON, Canada.
Organic traditions DARK CHOCOLATE GOLDEN BERRIES***DAIRY & SUGAR FREE 80% DARK CHOCOLATE;  Pack sizes  3.5oz/100g, UPC 8 54260 00263 8;  5.3 oz (150g), UPC 8 54260 00266 9;  12kg bulk boxes.
2550 units 3.5oz., 881 units 5.3 oz, 3462lbs bulk
Organic traditions DARK CHOCOLATE SACHA INCHI SEEDS***DAIRY & SUGAR FREE 80% DARK CHOCOLATE;   Pack sizes:  3.5oz/100g, UPC 8 54260 00709 1;  5.3 oz (150g), UPC 8 54260 00718 3;  12kg bulk boxes.
132 retail supermarkets in 6 states: CT, MA, NH, NY, PA, VT
''Price Chopper Hummus***TUSCAN WHITE BEAN***NET WT 10 OZ'' labels applied to clear plastic container with black rim on lid, ''Sell By Date 5/12/14''
Price Chopper, is recalling Price Chopper brand Tuscan White Bean Hummus due to undeclared milk allergen as a result of a labeling mix-up.
''Price Chopper Hummus***ROASTED GARLIC***NET WT 10 OZ'' labels applied to clear plastic container with black rim on lid, ''Sell By Date 5/14/14''
Price Chopper, is recalling Price Chopper brand Roasted Garlic Hummus due to a mix-up in nutrition panel and ingredients labeling.
Worldwide Distribution - USA (nationwide) and to Canada.
Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer   Spinal injection of anesthetics to provide regional anesthesia
catalog no. 333740, lot no. 61358613, exp. 4/30/2015:  Sprotte Spinal Tray, 24 gauge with 2mL Bupivacaine .75% with Dextrose 8.25% catalog no. 333741, lot no 61352071,exp. 12/31/2018: Sprotte Pencil Point Spinal Needle 24 gauge with Introducer  catalog no. 333742, lot no.61350129, exp. 5/31/2015: Sprotte Spinal Tray, 24 gauge with 2mL Lidocaine 5% with Dextrose 7.5%  catalog no. 560581, lot no.61354298, exp. 4/30/2015: Sprotte Spinal Tray 24 gauge with 2mL Bupivacaine .75% with Dextrose 8.25%
B.Braun Medical, Inc. (BBMI) has received reports of 24 gauge Sprotte Needles that are missing the accompanying introducer needles.
Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, and WV, and the countries of Australia, Canada, Chile, France, Germany, India, Ireland, Israel, Italy, Japan, Korea (South), Kuwait, Lebanon, Netherlands, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.
The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professional, including radiologists, physicians, technologists, clinicians, and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected wit the Centricity PACS infrastructure.
It has been identified that in a reject image workflow where multiple studies are simultaneously opened on the Centricity PACS RA1000 workstation and images are rejected from the active displayed study, images for the previously displayed study may also be rejected. The issue can occur with a previously displayed study that remains open in the background.    If one or more, but not all, images in the exam were inadvertently rejected, the image count in the work modes palette identifies fewer images; however, all of the images remain viewable.     For newly acquired exams, if the entire exam was inadvertently rejected, the RA1000 will return a message stating ''Unable to fetch this exam: No images in the exam''. The images would then need to be resent to PACS from the modality.     For historical exams, if the entire exam was inadvertently rejected, the RA1000 will return a message stating ''Unable to fetch this exam: No images in the exam'', and the exam is not available on the modality, a GE Healthcare Service representative would need to be contacted to restore the exam on the database.     There is a DelRejImg task in Centricity PACS versions 3.2 and higher, that if enabled and running, in conjunction with the inadvertently rejected image issue, poses a potential patient safety hazard due to data loss.     If the DelRejImg task runs, the inadvertently rejected images will be permanently deleted from PACS. If you do not have the DelRejImg task running, there is no potential hazard since the inadvertently rejected images remain on the system.     The deletion of the inadvertently rejected images could result in missed intervention or mis-diagnosis.
California, Utah, Idaho, Colorado, Nevada, Washington and Oregon.
Miravalle (brand) Achiote Molido Ground Annato (spice), 0.75oz.
Ground Annato spice has the potential to be contaminated with Salmonella.
PediaCare brand NIGHTTIME MULTI-SYMPTOM Cold, (diphenhydramine HCl 6.25 mg and phenylephrine HCl 2.5 mg), 4 FL OZ (118 mL), Distributed by Medtech Products, Inc., Tarrytown,NY ---- UPC 814832013544
Presence of Precipitate; small amounts of diphenydramine precipitated out of solution
PediaCare brand DAY & NIGHT Value Pack DAYTIME MULTI-SYMPTOM Cold (dextromethorphan HBr 5 mg and Phenylephrine HCl 2.5 mg) and NIGHTTIME MULTI-SYMPTOM Cold (diphenhydramine HCl 6.25 mg and phenylephrine HCl 2.5 mg), 4 FL oz (118 mL) bottles, one each of DAYTIME MULTI-SYMPTOM Cold, Distributed by Medtech Products, Inc., Tarrytown, NY --- UPC 814832013523
Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution
Medtronic Inc. Cardiac Rhythm Disease Management
Worldwide Distribution -- USA, including the territories of Guam and Puerto Rico; and, the countries of Albania, Algeria, Australia, Austria, Bahamas, Bangladesh, Belarus, Belgium, Benin, Bolivia, Bosnia And Herzegovina, Brazil, Bulgaria, Burkina Faso, Chile, Colombia, Costa Rica, Cote D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, Georgia, Germany, Greece, Guadeloupe, Honduras, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macau, Malaysia, Malta, Martinique, Mauritius, Mexico, Morocco, Nepal, Netherlands, Netherlands Antilles, New Caledonia, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Saudi Arabia, Senegal, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Yemen.
Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generator (EPG) Temporary Pacemaker (AAI/VVI). Used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. The device is typically connected to temporary transvenous, epicardial or myocardial pacing leads, in a bipolar configuration, using a patient cable (Medtronic Model 5433A or 5433V) or a surgical cable (Medtronic Model 5832 or 5832S).
Events related to a pacing rate outside of the intended setting, including events of sudden increased pacing rate up to the maximum setting of 180 pulses per minute (ppm), have been reported.  This is caused by the development of high resistance on internal electrical connector contacts due to oxidation over time.
*** US: Nationwide (AK, AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI); *** FOREIGN: Australia, Canada, China, Hong Kong, Iceland, Mexico, Netherlands, New Zealand, United Kingdom
Organic Cocoa Cassava bars, 1.59 oz (45 g), individually packaged in foil pouches and sold under the Dr. Mercola brand. Sold at retail locations in display cases containing 12 bars per display case. 12 display cases are packaged in each master case.
This voluntary recall has been initiated because the Dr. Mercola Organic Cocoa Cassava bars may contain undeclared milk protein.
Blood product, in which Quality Control Distribution/Distribution of product did not meet specifications, was distributed.
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
Blood product, in which Quality Control and Distribution of product did not meet specifications, was distributed.
Platelets Pheresis Leukocytes Reduced Irradiated
Blood products, in which platelet units failed residual white blood cell counts, were distributed.
Synthes ProDisc-C 2.0mm Milling Bit, Synthes 2.0mm Milling Bit HXC, Synthes 2.0mm Milling Bit with 2.35mm x 33.5mm Shaft, and Synthes 2.0mm Milling Bit with Flat Coupling. Spinal surgical instrument: The Synthes ProDisc-C 2.0mm Milling Bits are used as a part of the milling option for keel preparation of the vertebral bodies. The milling bits are coupled to a power tool and interface with the milling guide, which is connected to a trial implant for the keel preparation step.
Certain lots of the ProDisc-C 2.0mm Milling Bits have an increased potential to break during use.
Worldwide Distribution - USA including the states of AL, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, KS, LS, MD, MI, MN, MO, NH, NY, NC, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA and WI.,  and the countries of Australia, Austria, Dominican Rep, France, Germany, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Mexico, New Zealand, Norway, Philippines, Poland, Portugal, Republic Korea, Romania, Russian Fed, Saudi Arabia, Sweden, Switzerland, Turkey, U.A.E. and United Kingdom.
ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35);  ultrasound imaging system.
Software issues with ACUSON SC2000 ultrasound with software version 3/5 (VA35) -  may incorrectly display the color flow data in the wrong position and when Doppler Frequency is adjusted, the system does not restart the pulsed wave Doppler or continuous wave Doppler waveform.
Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belarus, Dominican Rep., France, Germany, India, Indonesia, Israel, Japan, Mexico, New Zealand, Norway, Philippines, Poland, Republic of Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Sweden, Switzerland, Turkey, U.A.E., Ukraine, and United Kingdom.
ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) and using Stress Echo Feature. Ultrasound imaging system.
Potential malfunction due to a software issue for ACUSON SC2000 ultrasound systems using software version 3.5 (VA35)  when using the stress echo feature which could cause the need for the study to be repeated.
IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the  creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography.
Model L9M21000 - Software versions: IMPAX CV 7.8 SU3/SU4 - OCR Service
Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service.
Distributed in the states of MN, CA, CO, TX, and IA.
MAGNETOM Aera magnetic resonance system.   Indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities.
Siemens discovered a processing error for the MAGNETOM Aera magnetic resonance system that may have resulted in some users not receiving Operator Manuals.
Cakes were sold to two retail stores in Portland, OR and one retail store in Vancouver, WA
Chernosliv  cake; Round 8 cake packaged in plastic dome. Net Weight: 2lb 15.8 oz. 1 unit/case;  Asian Bakery Homemade Cakes and Pastries, 1233 SE 174th Ave, Portland OR 97233.   No UPC code
Cakes are being recalled due to undeclared milk, wheat and soy lecithin.
Marquiz cake; Round 8 cake packaged in plastic dome. Net Weight: 2lb 15.8 oz. 1 unit/case;  Asian Bakery Homemade Cakes and Pastries, 1233 SE 174th Ave, Portland OR 97233.   No UPC code
Bells cake; Round 8 cake packaged in plastic dome. Net Weight: 2lb 13oz. 1 unit/case;  Asian Bakery Homemade Cakes and Pastries, 1233 SE 174th Ave, Portland OR 97233.   No UPC code
Cakes are being recalled due to undeclared wheat and soy lecithin.
Velvet cake; Round 8 cake packaged in plastic dome. Net Weight: 3lb 10oz. 1 unit/case;  Asian Bakery Homemade Cakes and Pastries, 1233 SE 174th Ave, Portland OR 97233.   No UPC code
Nationwide Distribution including AL, CT, IN, NC, NY, TX, and VA.
Visitec Anterior Chamber Cannula, .40x22mm (27Gx7/8in) REF 585006    Cannulae are intended to irrigate and or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where appropriate. These products are used in all sections of the eye. This cannula is a general use cannula mainly designed for the precise maintenance of optimum anterior chamber depth
Contains a sharp tip needle when the product should contain a blunt tip cannula.
Cefpodoxime Proxetil Tablets, USP, 200 mg, 20 Tablet Bottles, Rx Only. Manufactured in Austria by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540. NDC 0781-5439-20.
Presence of Particulate Matter: Presence of stainless steel particles.
Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100-count bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Water view Blvd., Parsippany, NJ 07054, USA. NDC: 64679-736-02.
Failed Dissolution Specifications: Failure of dissolution test observed at three month time point.