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U.S. Department of Health and Human Services

Enforcement Report - Week of June 4, 2014

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Drugs Burn 7 Capsules, supplied in 30 capsules bottle MFD: 07.18.2013, EXP: 07.17.2015 Class I Marketed Without an Approved NDA/ANDA: Undeclared sibutramine and phenolphthalein in Burn 7 dietary supplement Deseo Rebajar
Devices 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  ...
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Class II 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. Abbott Laboratories
Devices 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:  ...
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Class II 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. Abbott Laboratories
Devices 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. Class II 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. Abbott Laboratories
Drugs ParaGard T 380A - Intrauterine Copper Contraceptive, 176 mg of copper wire, Duramed Pharmaceuticals Inc, a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY 508004, exp. 4/2015, NDC 51285-204-01, Single Unit 508004, exp. 4/2015, NDC 51285-204-02, Carton of 5 Units Class II Non-sterility: due to a failed sterility test Teva Pharmaceuticals USA
Food 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, ½ Gal: 0 72000 15238 6; Community Market: Gal: 0 70554 27197 9; Dairymens: Gal: 0 72804 00190 3, ½ 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 & ½ 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, ½ Gal: 0 76310 05002 8, Qt: 0 76310 05300 5 & Pt: 0 76310 05250 3. IMS # 39-112; exp dates: 2/16/14, 2/17/14, 2/18/14, 2/19/14, 2/20/14. Class III 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. Borden Dairy Co Of Cincinnati Llc
Devices 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 Class II Samples containing fluorescein may show interference with the ADVIA Centaur® Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays. Siemens Healthcare Diagnostics, Inc
Devices 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 Class II Samples containing fluorescein may show interference with the ADVIA Centaur® Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays. Siemens Healthcare Diagnostics, Inc
Devices 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. 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 Class II Samples containing fluorescein may show interference with the ADVIA Centaur® Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays. Siemens Healthcare Diagnostics, Inc
Devices 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 Class II Samples containing fluorescein may show interference with the ADVIA Centaur® Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays. Siemens Healthcare Diagnostics, Inc
Devices 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 Class II Samples containing fluorescein may show interference with the ADVIA Centaur® Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays. Siemens Healthcare Diagnostics, Inc
Devices 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 Class II Samples containing fluorescein may show interference with the ADVIA Centaur® Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays. Siemens Healthcare Diagnostics, Inc
Devices 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 Class II Samples containing fluorescein may show interference with the ADVIA Centaur® Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays. Siemens Healthcare Diagnostics, Inc
Devices Siemens Linear Accelerator (LINAC) models. Product Usage: deliver X-ray radiation for therapeutic treatment of cancer material numbers and serial numbers: 1940035 2962 8139789 5833 8139789 5899 9401654 2113 1940035 2628 4504200 3066 4504200 3361 1940035 3873 1940035 2855 Class II 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. Siemens Medical Solutions USA, Inc
Devices LIFEPAK 1000 defibrillator. The LP1000 (in AED mode) is indicated for use on patients in cardiac arrest. Affected Part Numbers: 320371500XXX Class II 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. Physio-Control, Inc.
Food 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. CACAOXPSWEETZZGBEBLK001-12 and CACAOXPSWEETZZGBEBLK001-13 Class I Undeclared milk allergen Health Matters America Inc.
Food 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. CACAOXPSWEETZZDSIBLK001-12 and CACAOXPSWEETZZSIBLK001-13 Class I Undeclared milk allergen Health Matters America Inc.
Food "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" Sell By Date 5/12/14 Class I Price Chopper, is recalling Price Chopper brand Tuscan White Bean Hummus due to undeclared milk allergen as a result of a labeling mix-up. Golub Corporation
Food "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" Sell By Date 5/14/14 Class II Price Chopper, is recalling Price Chopper brand Roasted Garlic Hummus due to a mix-up in nutrition panel and ingredients labeling. Golub Corporation
Devices 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  ...
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Class II B.Braun Medical, Inc. (BBMI) has received reports of 24 gauge Sprotte Needles that are missing the accompanying introducer needles. B. Braun Medical, Inc.
Devices 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. Centricity PACS versions: 3.2; 3.2.0.1; 3.2.0.2; 3.2.1; 3.2.2; 3.2.2.1; 3.2.2.2; 3.2.2.3; 3.2.6; 3.2 SP7; 3.2 SP8; 4.0; 4.0.1; 4.0 SP3 Class II 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. GE Healthcare
Food Miravalle (brand) Achiote Molido Ground Annato (spice), 0.75oz. Lot Numbers: 0015 and 0018. UPC number: 712810005020. Class I Ground Annato spice has the potential to be contaminated with Salmonella. Miravalle Foods, Inc
Drugs 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 UPC 814832013544 Lots: Expiry Date 133196 01/2015 144273 02/2015 154090 09/2015 73242 05/2014 73243 05/2014 73244 05/2014 73824 06/2014 74207 06/2014 74303 06/2014 74460 06/2014 78805 09/2014 79265 10/2014 79266 10/2014 79573 09/2014 80456 06/2014 80457 07/2014 83746 01/2015 Class III Presence of Precipitate; small amounts of diphenydramine precipitated out of solution Prestige Brands Holdings
Drugs 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 UPC 814832013523 Lots: Expiry Date 148342 07/2015 148347 08/2015 149297 08/2015 149382 07/2015 149516 08/2015 152298 08/2015 73143 04/2014 73719 05/2014 74195 06/2014 74805 06/2014 75180 06/2014 79186 09/2014 79323 09/2014 Class III Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution Prestige Brands Holdings
Devices 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). serial numbers: PEP001001K, PEP001001P, PEP001002K, PEP001002P, PEP001003K, PEP001003P, PEP001004K, PEP001004P, PEP001005K, PEP001005P, PEP001006K, PEP001006P, PEP001007K, PEP001007P, PEP001008K, PEP001008P, PEP001009K, PEP001009P, PEP001010K, PEP001010P, PEP001011K, PEP001011P, PEP001012K, PEP001012P, PEP001013K, PEP001013P, PEP001014K, PEP001014P, PEP001015K, PEP001015P, PEP001016K, PEP001016P, PEP001017K, PEP001017P, PEP001018K, PEP001018P, PEP001019K, PEP001019P, PEP001020K, PEP001020P, PEP001021K, PEP001021P, PEP001022K, PEP001022P, PEP001023K, PEP001023P, PEP001024K, PEP001024P,  ...
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Class II 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. Medtronic Inc. Cardiac Rhythm Disease Management
Food 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. UPC Code: 8 13006 01142 6; Lot Numbers and Best By Dates: CD2601MC01, 04/27/14; 2313, 08/19/14; 2323, 08/20/14; 3503, 12/16/14; 3513, 12/16/14; 3523, 12/16/14; 3533, 12/16/14 Class II This voluntary recall has been initiated because the Dr. Mercola Organic Cocoa Cassava bars may contain undeclared milk protein. Mercola Group
Biologics Platelets Pheresis Leukocytes Reduced W03651400894; Class II Blood product, in which Quality Control Distribution/Distribution of product did not meet specifications, was distributed. LifeShare Blood Centers
Biologics Red Blood Cells Leukocytes Reduced W118813612226; Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. The Blood Alliance, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W115914110486 Class II Blood product, in which Quality Control and Distribution of product did not meet specifications, was distributed. Central California Blood Center
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W115914110414; Class II Blood products, in which platelet units failed residual white blood cell counts, were distributed. Central California Blood Center
Biologics Platelets Pheresis Leukocytes Reduced W115914110414; W115914110414; Class II Blood products, in which platelet units failed residual white blood cell counts, were distributed. Central California Blood Center
Devices 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. part number: 03.820.161s, with lot numbers: 5742507,5755970,5755971,5755972, 5755973,5755974,5828298,6336115, 6338099,6338100,6340029,6340030, 6344199,6344200,6363601,6385892, 6407046,6431260,6431261,6460402, 6503360,6526127,6571070,6571073, 6571074,6601985,6636946,6636947, 6636948,6653819,6653820,6670383, 6691341,6691342,6718933,6718934, 6718935,6740611,6794651,6794652, 6794653,6794654,6794655 part number: 03.820.1638 with lot numbers: 5742506,5755978,5755979,5755980, 5755981,5755982,5828299,5828300, 6320586,6336108,6336110,6336111, 6340033,6344201,6344202,6363602, 6385893,6431262,6431263,6460403, 6503361,6571075,6601986,6601987, 6636949,6636950,6636951,6653810, 6653818,6670382,6691343,6691344, 6718938,6740615,6740616,6745821, 6770474,6770475,6770476,6770477, 6770478,6794657,6794658 part number: 03.820.167S with lot numbers: 5755983,5755984,5755987,5755988, 5755989,5755985,5755986,5755990, 5828302,6338101,6338102,6338103, 6338104,6338106,6338107,6338108, 6338109,6344205,6471089,6670381, 6718939,6718940,6718941,6843907, 6843906,6856252,6856253,6867662, 6867661,6901712,6901713,6919726, 6919727,6919728,6901710,6901711, 6921717,6921718,6940357,6960192, 6960193,6983033,7006496,7055427 part number: 03.820.169S with lot numbers: 6066520,6113671,6113633,6159883, 6180175,6338068,6338098,6344206, 6363603,6407047,6431264,6460404, 6526128,6571078,6670384,6745820, 6770479,6770480 Class II Certain lots of the ProDisc-C 2.0mm Milling Bits have an increased potential to break during use. Synthes, Inc.
Devices ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasound imaging system. Model number 10433816; Serial numbers: US: 400290 400425 400439 400441 400443 400447 401176 401591 400763 400787 400789 400790 400791 400792 400794 400797 400063 400860 400868 400872 400873 400877 401041 401187 401441 401540 401590 401602 401662 401696 401638 401641 400174 400882 401612 401501 401507 401561 401378 400297 401423 401429 401550 401491 401494 401562 401572 401584 401621 400803 400821 400570 401010 401020 401235 401252 401564 401611 400998 400999 401601 401648 400979 401625 401631 400234 400312 400972 401433 400336 401645 400108 400177 400203 400313 400650 400663 400664 400176 400712 400716 401565 400128 400142 400782 400887 400889 401043 401554 400067 401257 401320 401559 401576 401633 401583 400875 400912 400925 400474 400902 401387 401476 401477 401547 401496 401567 401569 401570 401597 401607 401608 401618 401669 400630 401558 401587 401644 400227 400473 400577 400649 401294 401600 401596 ROW: 400652 400733 400737 400746 401437 401443 401478 401495 401188 401191 401650 400546 400945 401506 401371 401325 401393 401403 401543 401571 401580 401581 401613 401620 401623 400302 400348 400347 400553 400558 400726 400995 400996 401120 401123 401209 401260 401288 401338 401344 401442 401452 401551 401555 401556 401522 401560 401577 401579 401588 401589 401603 401604 401606 401643 401699 401630 401676 400125 400200 401434 401658 401661 401626 401435 401498 401217 401389 401431 401563 401585 401605 401687 400155 400180 400307 400704 401428 401451 401541 401521 401582 401594 401595 401624 401632 401637 401640 401666 401688 401689 401695 401004 401508 401546 401519 401627 400247 400263 400511 401045 400497 401664 400284 400252 401566 401502 400655 400214 401394 401367 401617 401634 401651 401652 401657 401659 401663 401665 401681 401685 401686 401694 401698 400253 400836 400840 401118 400218 400990 401127 40118. 0 Class II 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. Siemens Medical Solutions USA, Inc.
Devices ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) and using Stress Echo Feature. Ultrasound imaging system. ACUSON SC2000 model number: 10433816; Stress Echo Feature model number: 1044966 Serial numbers - USA: 400290 400425 400439 400441 400443 400447 401176 400787 400789 400790 400791 400792 400794 400797 400063 400877 401187 401441 401590 401602 401638 400174 401612 401501 401507 401561 400297 401423 401429 401550 401491 401494 401562 401572 401584  ...
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Class II 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. Siemens Medical Solutions USA, Inc.
Devices 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 Class II Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service. AGFA Corp.
Devices 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. model # 10432914 with serial numbers: 52126 52135 52108 52025 52101 Class II Siemens discovered a processing error for the MAGNETOM Aera magnetic resonance system that may have resulted in some users not receiving Operator Manuals. Siemens Medical Solutions USA, Inc
Food 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 No code. Class II Cakes are being recalled due to undeclared milk, wheat and soy lecithin. Asian Bakery
Food 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 No code. Class II Cakes are being recalled due to undeclared milk, wheat and soy lecithin. Asian Bakery
Food 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 No code. Class II Cakes are being recalled due to undeclared wheat and soy lecithin. Asian Bakery
Food 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 No code. Class II Cakes are being recalled due to undeclared wheat and soy lecithin. Asian Bakery
Devices 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 Lot number: 3079324 Class II Contains a sharp tip needle when the product should contain a blunt tip cannula. Beaver-Visitec International Inc.
Drugs 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. Lot #: DZ4056, Expiry: 11/2015; Lot # DZ4057, Expiry: 01/2016 Class II Presence of Particulate Matter: Presence of stainless steel particles. Sandoz, Inc
Drugs 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. Lot #: LN11423, Expiry: 8/15/15 Class II Failed Dissolution Specifications: Failure of dissolution test observed at three month time point. Wockhardt Usa Inc.
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