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U.S. Department of Health and Human Services

Enforcement Report - Week of August 5, 2015

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Red Blood Cells Leukocytes Reduced 004V46424 Class II Blood products, collected from ineligible donors, were distributed. ARC Blood Services, New England Region
Biologics Red Blood Cells 004LJ62022 Class II Blood products, collected from ineligible donors, were distributed. ARC Blood Services, New England Region
Biologics Blood and Blood Products for Reprocessing 004LJ62022; 004V46424 Class III Blood products, collected from ineligible donors, were distributed. ARC Blood Services, New England Region
Biologics Platelets Pheresis Leukocytes Reduced 004GC26300P1; 004GC26300P2 Class II Platelets, lacking assurance of proper leukoreduction, were distributed. ARC Blood Services, New England Region
Biologics Red Blood Cells Leukocytes Reduced 033FM06914, 033FM06915, 033FM06926, 033FM06930, 033FM06935, 033FM06941, 033FM06950, 033FM06953, 033FM06956, 033FM06957, 033FM06958, 033FM06960, 033FM06963, 033FM06964, 033FM06971, 033FM06972, 033FM06973, 033FM06974, 033FM06975, 033FM06976, 033FM06979, 033FM06987, 033FM06990, 033FM06992, 033FM06994, 033FM06995, 033FN07149, 033FN07156, 033FN07159, 033GL84081, 033GL84089, 033GL84134 Class II Blood products, associated with invalid testing results, were distributed. American National Red Cross (The)
Biologics Platelets Pooled Leukocytes Reduced 033FM06918 Pool ID 6670; 033FM06922 Pool ID 6675; 033FM06929 Pool  ...
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Class II Blood products, associated with invalid testing results, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced Irradiated 033FM06944; 033FM06948; 033GL84113 Class II Blood products, associated with invalid testing results, were distributed. American National Red Cross (The)
Biologics Platelets Leukocytes Reduced 033FM06915, 033FM06923, 033FM06925, 033FM06935, 033FM06936, 033FM06956, 033FM06962, 033FM06964, 033FM06965, 033FM06967, 033FM06970, 033FM06973, 033FM06974, 033FM06975, 033FM06976, 033FM06978, 033FM06979, 033FM06980, 033FM06981, 033FM06987, 033FM06990, 033FM06991, 033FM06992, 033FM06994, 033FM06995, 033FN07151, 033FN07159, 033FN07160, 033FN07164, 033FN07166, 033GL84081, 033GL84089, 033GL84098, 033GL84099, 033GL84100, 033GL84108, 033GL84118, 033GL84134, 033KZ11977, 033LQ77899, 033LQ77900, 033LQ77901, 033LQ77903, 033LQ77909, 033LQ77911, 033LQ77914, 033LQ77915, 033LQ77916, 033LQ77923, 033LQ77927,  ...
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Class II Blood products, associated with invalid testing results, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 012FW69200, 012FQ09318, 012FY39085, 012FY37438, 012FG42694, 012KZ52153, 012FR22039, 012FY34554, 012FY34627, 012FG40890, 012GS03704, 012GS04118, 012FQ09245, 012FQ09272, 012FW68313, 012FW68319, 012FT83422, 012FS60111, 012FR25598, 012FV51535, 012FS59634, 012FS59644, 012FW67486, 012FR25054, 012FW67312, 012FY37836, 012FQ07027, 012FY38178, 012FY38188, 012GS02295, 012FX27243, 012FR22603, 012FY35081, 012FG42082, 012FR22066, 012FX24795, 012FG40885, 012KZ50782, 012FX24784, 012FW62169, 012FR21890 Class II Blood products, collected from a donor who visited a malarial endemic area, were distributed. American National Red Cross (The)
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 012LH32864, 012LH32864, 012KV32636, 012KV32636, 012FM19243, 012FM19243, 012KY32298, 012KY32298, 012KY32300, 012KY32300 Class II Blood products, collected from a donor who visited a malarial endemic area, were distributed. American National Red Cross (The)
Biologics Platelets Pheresis Leukocytes Reduced W050911078714; W050911077797; Class II Blood products, collected from ineligible donors, were distributed. HCSC-Blood Center
Biologics Red Blood Cells W050911080709; Class III Blood products, collected from ineligible donors, were distributed. HCSC-Blood Center
Biologics Fresh Frozen Plasma W050911080709; Class III Blood products, collected from ineligible donors, were distributed. HCSC-Blood Center
Food Nut Free Pesto, packaged in a institutional size 28 lbs. and 30 lbs. container, sold under brand Rising Sun Farms, UPC 0 18646 48075 9 Lot #14260 Best By: 09/17/15 Class I Nut Free Pesto is recalled due to a contamination with Listeria monocytogenes. Rising Sun Farms Inc
Devices MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-1511; NGP 640G 1.8ml (mg/dL), Model No. 1512; NGP 640G PLGM 3ml (mmol/L), Model No. MMT-1711; NGP 640G PLGM 3ml (mg/dL), Model No. MMT-1712. n/a Class II Medtronic MiniMed is recalling the MiniMed 620G and 640G insulin pumps because there are certain scenarios where the set Bolus screen will not timeout, which could cause confusion by showing a bolus amount that is no longer appropriate. Medtronic MiniMed Inc.
Devices Computed Tomography X-ray Systems Brilliance CT 64-channel with Essence technology. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Brilliance CT 64-channel with Essence technology: Model #728231; Serial #s: 9654, 95130, 95157 & 95504. Class II The following issues were discovered through internal testing: · Fast Get Ready incorrectly enabled during service procedures. · Contrast annotation incorrectly missing for some images when manual contrast was administered. · Dot artifact present, intermittently, after startup. · Heart Rate measured value incorrectly remains constant for some heart rate change conditions. · Tube heat predictor fails to warn of overheat condition for long scans. Philips Medical Systems (Cleveland) Inc
Devices Computed Tomography X-ray systems Brilliance iCT, Philips Healthcare System. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Brilliance iCT: Model #728306; Serial #s: 85012, 85013, 85014, 100029, 100038, 100040, 100053, 100058, 100094, 100099, 100133, 100140, 100162, 100178, 100236, 100244, 100373, 100399, 100408, 100411, 100416, 100441, 100450, 100454, 100461, 100463, 100465, 100466, 100498, 100503, 100506, 100507, 100508, 100509, 100511, 100512, 100517 & 100518. Class II The following issues were discovered through internal testing: · Fast Get Ready incorrectly enabled during service procedures. · Contrast annotation incorrectly missing for some images when manual contrast was administered. · Dot artifact present, intermittently, after startup. · Heart Rate measured value incorrectly remains constant for some heart rate change conditions. · Tube heat predictor fails to warn of overheat condition for long scans. Philips Medical Systems (Cleveland) Inc
Devices Computed Tomography X-ray Systems Brilliance iCT SP. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Model #728311; Serial #s: 200047 & 200121 Class II The following issues were discovered through internal testing: · Fast Get Ready incorrectly enabled during service procedures. · Contrast annotation incorrectly missing for some images when manual contrast was administered. · Dot artifact present, intermittently, after startup. · Heart Rate measured value incorrectly remains constant for some heart rate change conditions. · Tube heat predictor fails to warn of overheat condition for long scans. Philips Medical Systems (Cleveland) Inc
Devices Computed Tomography X-ray Systems Ingenuity Core. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Model #728321; Serial #s: 31001, 52007, 52008, 52010, 52012, 52013, 52018, 52020, 52021, 52024, 52026, 52030, 52031, 52032, 52033, 52034, 52035, 52036, 52037, 52038, 52039, 52042, 52043, 52046, 52052, 52053, 52054, 52055, 52057, 52058, 310001, 310002, 310003, 310009, 310017, 310052, 310055, 310059, 310064, 310069, 310070, 310071, 310081, 310087, 310088, 310096,  ...
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Class II The following issues were discovered through internal testing: · Fast Get Ready incorrectly enabled during service procedures. · Contrast annotation incorrectly missing for some images when manual contrast was administered. · Dot artifact present, intermittently, after startup. · Heart Rate measured value incorrectly remains constant for some heart rate change conditions. · Tube heat predictor fails to warn of overheat condition for long scans. Philips Medical Systems (Cleveland) Inc
Devices Computed Tomography X-ray Systems Ingenuity Core 128. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Model #728323; Serial #s: 32010, 32013, 32015, 32016, 32018, 32021, 32024, 32026, 32032, 32033, 32034, 32036, 32037, 32041, 32042, 32043, 32044, 32046, 32047, 32048, 32049, 32051, 32052, 32053, 32054, 32055, 32057, 32059, 32060, 32062, 32064, 32065, 32067, 32068, 32069, 32070, 32072, 32073, 32074, 32075, 32077, 32078, 32079, 32080, 32082, 32083,  ...
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Class II The following issues were discovered through internal testing: · Fast Get Ready incorrectly enabled during service procedures. · Contrast annotation incorrectly missing for some images when manual contrast was administered. · Dot artifact present, intermittently, after startup. · Heart Rate measured value incorrectly remains constant for some heart rate change conditions. · Tube heat predictor fails to warn of overheat condition for long scans. Philips Medical Systems (Cleveland) Inc
Devices Computed Tomography X-ray Systems Ingenuity CT scanners. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Model #728326; Serial #s: 30003, 30004, 30005, 30006, 30007, 30008, 30009, 30011, 30012, 30013, 30015, 30018, 30019, 30020, 30025, 32086, 32093, 32107, 52023, 52044, 52051, 300003, 300004, 300005, 300010, 300011, 300012, 300013, 300014, 300016, 300017, 300019, 300020, 300021, 300024, 300025, 300027, 300028, 300029, 300031, 300032, 300033, 300034, 300035, 300036, 300037,  ...
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Class II The following issues were discovered through internal testing: · Fast Get Ready incorrectly enabled during service procedures. · Contrast annotation incorrectly missing for some images when manual contrast was administered. · Dot artifact present, intermittently, after startup. · Heart Rate measured value incorrectly remains constant for some heart rate change conditions. · Tube heat predictor fails to warn of overheat condition for long scans. Philips Medical Systems (Cleveland) Inc
Devices ANSPACH - Fluted Drum, Side Cut only 10MM x 14MM , REF L-10DRC-G1 Cutting shaping bone including spine and cranium. REF L-10DRC-G1 ALL lot numbers Class II G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater. The Anspach Effort, Inc.
Devices ANSPACH - Fluted Drum, Side Cut only 5MM x 14MM , REF L-5DRC-G1. Cutting shaping bone including spine and cranium. REF L-5DRC-G1 ALL lot numbers Class II G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater. The Anspach Effort, Inc.
Devices ANSPACH - Extra Coarse Diamond Drum, 6.8MM x 10.6MM REF L-68DRMDX-G1 Cutting shaping bone including spine and cranium. REF L-68DRMDX-G1 ; ALL lot numbers Class II G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater. The Anspach Effort, Inc.
Devices ANSPACH - Fluted Drum, Side Cut only, 6MM x 14MM REF L-6DRC-G1 Cutting shaping bone including spine and cranium. REF L-6DRC-G1 ; ALL lot numbers Class II G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater. The Anspach Effort, Inc.
Devices ANSPACH - Fluted Acorn, 7MM REF L-7AC-G1 Cutting shaping bone including spine and cranium. REF L-7AC-G1 ; ALL lot numbers Class II G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater. The Anspach Effort, Inc.
Devices ANSPACH - Fluted Drum, Side Cut Only; 7MM x 14MM REF L-7DRC-G1 Cutting shaping bone including spine and cranium. REF L-7DRC-G1 ; ALL lot numbers Class II G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater. The Anspach Effort, Inc.
Devices ANSPACH - Fluted Barrel; 8MM x 12.5MM REF L-8BA-G1 Cutting shaping bone including spine and cranium. REF L-8BA-G1 ; ALL lot numbers Class II G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater. The Anspach Effort, Inc.
Devices ANSPACH - Fluted Barrel; 8MM x 12.5MM REF L-8BA-G1 Cutting shaping bone including spine and cranium. REF L-8BA-G1 ; ALL lot numbers Class II G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater. The Anspach Effort, Inc.
Devices ANSPACH - 8MM x 14MM Fluted Drum, Side Cut Only; REF L-8DRC-G1. Cutting shaping bone including spine and cranium. REF L-8DRC-G1 ; ALLlot numbers Class II G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater. The Anspach Effort, Inc.
Devices ANSPACH - Extra Coarse Diamond Ball; 8MM REF L-8DX-G1 Cutting shaping bone including spine and cranium. REF L-8DX-G1 ; ALL lot numbers Class II G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater. The Anspach Effort, Inc.
Devices ANSPACH - Fluted Ball; 9MM REF L-9B-G1 Cutting shaping bone including spine and cranium. REF L-9B-G1 ; ALL lot numbers Class II G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater. The Anspach Effort, Inc.
Devices ANSPACH - Fluted Drum, Side Cut Only; 9MM x 14 MM REF L-9DRC-G1 Cutting shaping bone including spine and cranium. REF L-9DRC -G1 ; ALL lot numbers Class II G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater. The Anspach Effort, Inc.
Devices ANSPACH - 3MM Course Diamond Ball, 2 MM Shaft Exposure; REF M-3DC-2-G1 Cutting shaping bone including spine and cranium. REF M-3DC-2-G1 ; ALL lot numbers Class II G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater. The Anspach Effort, Inc.
Devices ANSPACH - 3MM Fluted Ball, 2 MM Shaft Exposure; REF M-3SB-2-G1. Cutting shaping bone including spine and cranium. REF M-3SB-2-G1 ; ALL lot numbers Class II G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater. The Anspach Effort, Inc.
Devices ANSPACH - 4MM x 11 MM Fluted Barrel, 14 Flutes; REF M-4BA-A-G1. Cutting shaping bone including spine and cranium. REF M-4BA-A-G1 ; ALL lot numbers Class II G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater. The Anspach Effort, Inc.
Devices ANSPACH - 5MM Fluted Ball, 2 mm Shaft Exposure; REF M-5B-2-G1. Cutting shaping bone including spine and cranium. REF M-5B-2-G1 ; ALL lot numbers Class II G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater. The Anspach Effort, Inc.
Devices ANSPACH - 5MM x 11.3MM Fluted Barrel; REF M-5BA-A-G1 Cutting shaping bone including spine and cranium. REF M-5BA-A-G1 ; ALL lot numbers Class II G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater. The Anspach Effort, Inc.
Devices ANSPACH - 6MM x 11.3MM Fluted Barrel; REF M-6BA-A-G1 Cutting shaping bone including spine and cranium. REF M-6BA-A-G1 ; ALL lot numbers Class II G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater. The Anspach Effort, Inc.
Devices ANSPACH - 6MM Coarse Diamond Ball, 2 mm Shaft Exposure; REF M-6DC-2-G1 Cutting shaping bone including spine and cranium. REF M-6DC-2-G1 ; ALL lot numbers Class II G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater. The Anspach Effort, Inc.
Devices ANSPACH - 7MM Fluted Acorn; REF M-7AC-G1 Cutting shaping bone including spine and cranium. REF M-7AC-G1 ; ALL lot numbers Class II G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater. The Anspach Effort, Inc.
Devices ANSPACH - 7MM Extra Coarse Diamond Ball; REF M-7DX-G1 Cutting shaping bone including spine and cranium. REF M-7DX-G1 ; ALL lot numbers Class II G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater. The Anspach Effort, Inc.
Devices ANSPACH - 8MM x 12.5MM Fluted Barrel; REF M-8BA-G1 Cutting shaping bone including spine and cranium. REF M-8BA-G1 ; ALL lot numbers Class II G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater. The Anspach Effort, Inc.
Devices ANSPACH - 4MM Fluted Ball, Extends 27MM; REF M-4B-27-G1. Cutting shaping bone including spine and cranium. REF M-4B-27-G1 ; ALL lot numbers. Class II G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater. The Anspach Effort, Inc.
Devices ANSPACH - 5MM Fluted Ball, Extends 27MM; REF M-5B-27-G1. Cutting shaping bone including spine and cranium. REF M-5B-27-G1 ; ALL lot numbers. Class II G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater. The Anspach Effort, Inc.
Devices ANSPACH -1.5MM x 7.5MM Cylindrical Carbide Drum, Extends 25MM; REF S-15DRMC-L-G1. Cutting shaping bone including spine and cranium. REF S-15DRMC-L-G1 ; ALL lot numbers. Class II G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater. The Anspach Effort, Inc.
Devices ANSPACH -3MM Coarse Diamond Ball,72MM Shaft Exposure; REF S-3SDC-22-G1. Cutting shaping bone including spine and cranium. REF S-3SDC-22-G1 ; ALL lot numbers. Class II G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater. The Anspach Effort, Inc.
Devices ANSPACH -4MM Carbide Fluted Ball, Extends 27MM; REF S-4BL-C-G1. Cutting shaping bone including spine and cranium. REF S-4BL-C-G1 ; ALL lot numbers. Class II G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater. The Anspach Effort, Inc.
Devices ANSPACH -4MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-4DC-22-G1 Cutting shaping bone including spine and cranium. REF S-4DC-22-G1 ; ALLlot numbers. Class II G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater. The Anspach Effort, Inc.
Devices ANSPACH - 4MM Diamond Ball, Extends 27MM; REF S-4D-L-G1 all lot numbers Cutting shaping bone including spine and cranium. REF S-4D-L-G1 ; ALL lot numbers. Class II G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater. The Anspach Effort, Inc.
Devices ANSPACH - 5MM Fluted Ball, 2MM Shaft Exposure; REF S-5B-2-G1 Cutting shaping bone including spine and cranium. REF S-5B-2-G1 ; ALL lot numbers. Class II G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater. The Anspach Effort, Inc.
Devices ANSPACH - 5MM Diamond Ball, 2MM Shaft Exposure; REF S-5D-2-G1 Cutting shaping bone including spine and cranium. REF S-5D-2-G1 ; ALL lot numbers. Class II G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater. The Anspach Effort, Inc.
Devices ANSPACH - 5MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-5DC-22-G1 Cutting shaping bone including spine and cranium. REF S-5DC-22-G1 ; ALL lot numbers. Class II G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater. The Anspach Effort, Inc.
Devices ANSPACH - 2.3MM Fluted Matchstick, Extends 22MM; REF S-8N-L-G1 Cutting shaping bone including spine and cranium. REF S-8N-L-G1 ; ALL lot numbers. Class II G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater. The Anspach Effort, Inc.
Devices ANSPACH - 3MM Fluted Matchstick, Extends 8.9MM, Less Aggressive; REF S-8NS-M-G1 Cutting shaping bone including spine and cranium. REF S-8NS-M-G1 ; ALL lot numbers. Class II G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater. The Anspach Effort, Inc.
Devices Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002. Software: 159700.. Intensive care ventilation of adult and pediatric patients and optionally infant and neonatal patients. Software version 2.20 and 2.41, Class II Customer reports that the ventilator display can freeze. Ventilation continues but the information is no longer displayed on the screen and the user can no longer operate the device. Hamilton Medical, Inc.
Devices SYMMETRY SURGICAL DISPOSABLE TOWEL CLAMP, REF 19-4137, STERILE EO, Rx only. Apply clamps parallel to the skin with the angled jaws forming a "V" shape between clamp and drape. 149053, 149129, 149143, 149604, 149605, 149606, 149682, 149692, 149837, 149853, 154454, 154455, 154456, 154457, 185696, 228161, 229609, 230233, 259154, 259156, 259160, 268906, 268910, and 271548. Class II Lack of sterility assurance. Symmetry Surgical, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated W036815171070; Class II Blood products, in which quality control and distribution of products did not meet specifications, were distributed. OneBlood, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W036815171070; W036815171027; W036815171027; Class II Blood products, in which quality control and distribution of products did not meet specifications, were distributed. OneBlood, Inc.
Devices Prism Medical P-440 Portable Ceiling Lift; PN 303070 and 303070R (refurbished); Patient lift with weight specification of 440 lbs (200 kg). Product Usage: The P-440 lift is a lifting aid used by health care professionals and those providing care in the home to lift, position, and transfer clients or a disabled family member. The ceiling lift makes it possible to move mobility impaired individuals with minimal strain or risk to the caregiver, while providing complete safety, dignity, and comfort for the client or family member. All serial numbers. Class II There is a potential the sling loops may not stay attached to the carry bar hooks. ErgoSafe Products, LLC (DBA) Prism Medical
Devices Prism Medical P-600 Portable Ceiling Lift; PN 303090. Patient lift with weight specification of 600 lbs (273 kg). Product Usage: The P-600 lift is a lifting aid used by health care professionals and those providing care in the home to lift, position, and transfer clients or a disabled family member. The ceiling lift makes it possible to move mobility impaired individuals with minimal strain or risk to the caregiver, while providing complete safety, dignity, and comfort for the client or family member. All serial numbers. Class II There is a potential the sling loops may not stay attached to the carry bar hooks. ErgoSafe Products, LLC (DBA) Prism Medical
Biologics Red Blood Cells Leukocytes Reduced W11701500689600; W11701501002300; Class II Blood products, in which labeling was incorrect and/ or missing information, were distributed. Blood Centers of the Pacific - Irwin Center
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W092915102453; Class III Blood products, in which the concentration of apheresis products exceeded the maximum limit, were distributed. Poudre Valley Health Care, Inc. Blood Bank
Biologics Platelets Pheresis Leukocytes Reduced W092915102453; Class III Blood products, in which the concentration of apheresis products exceeded the maximum limit, were distributed. Poudre Valley Health Care, Inc. Blood Bank
Devices InjectionPlasty 1.0 Bone Void Filler; an injectable and biocompatible calcium phosphate bone void filler. Sterilized using irradiation. The single-use InjectionPlasty 1.0 Kit contains the necessary components for mixing and delivery of the bone void filler. The InjectionPlasty 1.0 sterile kit contains: Calcium Phosphate Powder, Dilute Sodium Silicate Liquid, a Mixing System, Targeting K-Wires and a Delivery Needle (Cannula). Model number 10801210. InjectionPlasty 1.0 is indicated to fill bony voids or gaps of the skeletal system Model number: 10801210: Lot Numbers Expiration Dates 13022501 8/31/2015 13052305 11/30/2015 13120901 5/31/2016 14051901 11/30/2016 14100101 3/31/2017 15042701 10/13/2017 Class II Reports of venous uptake, DVT, pulmonary embolism in patients who were implanted with Injection Plasty Bone Void Filler. Skeletal Kinetics, Llc
Food Fat Free Pasteurized Prepared Cheese Product: SOUTHHOME 12/12OZ AMERICAN FAT FREE YELLOW, 0788001319. ROUNDYS 12/12OZ AMER FAT FREE YLW, 1115051105. SHUR FINE 12/12OZ AMER FAT FREE YLW, 1116146131. HAGGEN 12/12OZ AMER FAT FREE YLW, 269845607.5 FOODDCLUB 12/12OZ AMER FAT FREE YLW, 368004543.2. EVERYDAY 12/10.7OZ FF IWS AMER PROC YLW, 4130300847. BORDEN 12/12OZ AMER FAT FREE YLW, 5300000675. HYVEE 12/12OZ FAT FREE AMER, 7545009328. BRKSHIRE 12/12OZ AMER FAT FREE YLW, 9282510103. Sell By/Use By 8/10/2015 to 4/30/2016 Class II Dairy Farmers of America Inc. is recalling a number of cheese products due that a piece of plastic film strip might remain attached to the cheese slice upon peeling the film from the product. Dairy Farmers OF America Inc
Food Imitation Pasteurized Process Cheese Food: SANDWICH MATE 24/6.56OZ IMITATION WHITE, 7103026288. VALU TIME 12/10.67 OZ AMER IMITATION WHITE, 1122509215. SANDWICH MATE 12/8OZ AMER IMITATION PASTEURIZED PROCCESS.99 WHITE, 7103025055. Sell By/Use By 8/10/2015 to 4/30/2016 Class II Dairy Farmers of America Inc. is recalling a number of cheese products due that a piece of plastic film strip might remain attached to the cheese slice upon peeling the film from the product. Dairy Farmers OF America Inc
Food American Pasteurized Cheese Product: MARVELLA 12OZ 340G AMERICAN PASTEURIZED CHEESE, SINGLES, 5193319275. Sell By/Use By 8/10/2015 to 4/30/2016 Class II Dairy Farmers of America Inc. is recalling a number of cheese products due that a piece of plastic film strip might remain attached to the cheese slice upon peeling the film from the product. Dairy Farmers OF America Inc
Food Flavored Pasteurized Prepared Cheese Product: HYVEE 12/12OZ PEPPER JACK CHS PROD, 7545009334. Sell By/Use By 8/10/2015 to 4/30/2016 Class II Dairy Farmers of America Inc. is recalling a number of cheese products due that a piece of plastic film strip might remain attached to the cheese slice upon peeling the film from the product. Dairy Farmers OF America Inc
Food FLAVORED PASTEURIZED PREPARED CHEESE PRODUCT BORDEN SENSATIONS 12/8OZ APPLEWOOD BACON CHEDDAR 5300000980 Sell By/Use By 8/10/2015 to 4/30/2016 Class II Dairy Farmers of America Inc. is recalling a number of cheese products due that a piece of plastic film strip might remain attached to the cheese slice upon peeling the film from the product. Dairy Farmers OF America Inc
Food Non-Fat Pasteurized Prepared Cheese Product: FOOD CLUB 12/12OZ AMER FAT FREE YELLOW, 3680045432. SHOPPRITE 12/12OZ AMER FAT FREE YLW, 4119045837. MEIJER 12/12 OZ AMERICAN FAT FREE COLOR, 4125056702. SCHNUCKS 12/12OZ AMER FAT FREE YLW, 4131858109. Sell By/Use By 8/10/2015 to 4/30/2016 Class II Dairy Farmers of America Inc. is recalling a number of cheese products due that a piece of plastic film strip might remain attached to the cheese slice upon peeling the film from the product. Dairy Farmers OF America Inc
Food Swiss Style Cheese Alternative: LISANATTI FOODS, SOY- SATION 12/8OZ SWISS STYLE SLICES, 4529680255. Sell By/Use By 8/10/2015 to 4/30/2016 Class II Dairy Farmers of America Inc. is recalling a number of cheese products due that a piece of plastic film strip might remain attached to the cheese slice upon peeling the film from the product. Dairy Farmers OF America Inc
Food White Cheddar Flavor Cheese Alternative: SOYA KAAS 12/8OZ WHITE CHEDDAR FLAVOR SLICES, 7801600478. Sell By/Use By 8/10/2015 to 4/30/2016 Class II Dairy Farmers of America Inc. is recalling a number of cheese products due that a piece of plastic film strip might remain attached to the cheese slice upon peeling the film from the product. Dairy Farmers OF America Inc
Food Reduced Fat Pasteurized Prepared Cheese Product: BORDEN 12/12OZ 2% SHARP CHEDDAR YELLOW, 5300000615. Sell By/Use By 8/10/2015 to 4/30/2016 Class II Dairy Farmers of America Inc. is recalling a number of cheese products due that a piece of plastic film strip might remain attached to the cheese slice upon peeling the film from the product. Dairy Farmers OF America Inc
Food American Cheddar Flavor Slices: SOYA KAAS 12/8OZ AMERICAN CHEDDAR FLAVOR SLICES, 7801600480. Sell By/Use By 8/10/2015 to 4/30/2016 Class II Dairy Farmers of America Inc. is recalling a number of cheese products due that a piece of plastic film strip might remain attached to the cheese slice upon peeling the film from the product. Dairy Farmers OF America Inc
Food Reduced Fat Pasteurized Prepared Cheese Product: MEIJER 12/12OZ 2PCT AMER YLW,4125005136. ESSENTIAL EVERYDAY 12/10.7 OZ 2% AMER PROC YLW, 4130300844. BORDEN 12/6.56OZ 2% AMER YLW, 5300000605. BORDEN 12/10.67OZ 2% AMER SINGLES,2.99, 5300000693. HARRIS TEETER 12/12OZ 2% AMER YLW, 7203660084. Sell By/Use By 8/10/2015 to 4/30/2016 Class II Dairy Farmers of America Inc. is recalling a number of cheese products due that a piece of plastic film strip might remain attached to the cheese slice upon peeling the film from the product. Dairy Farmers OF America Inc
Food Reduced Fat Pasteurized Prepared Cheese Product: BORDEN 12/12OZ 2% PEPPER JACK WHITE, 5300000619. Sell By/Use By 8/10/2015 to 4/30/2016 Class II Dairy Farmers of America Inc. is recalling a number of cheese products due that a piece of plastic film strip might remain attached to the cheese slice upon peeling the film from the product. Dairy Farmers OF America Inc
Food Reduced Fat Pasteurized Prepared Cheese Product: BORDEN 12/6.56OZ 2% LIGHT MOZZARELLA REDUCED FAT SLICES, 5300001605. Sell By/Use By 8/10/2015 to 4/30/2016 Class II Dairy Farmers of America Inc. is recalling a number of cheese products due that a piece of plastic film strip might remain attached to the cheese slice upon peeling the film from the product. Dairy Farmers OF America Inc
Food Reduced Fat Pasteurized Prepared Cheese Product: BORDEN 12/12OZ 2PCT AMER WHT, 5300001614. Sell By/Use By 8/10/2015 to 4/30/2016 Class II Dairy Farmers of America Inc. is recalling a number of cheese products due that a piece of plastic film strip might remain attached to the cheese slice upon peeling the film from the product. Dairy Farmers OF America Inc
Food SHOP RITE 12/12OZ AMER NON-FAT WHITE, 4119045823 Sell By/Use By 8/10/2015 to 4/30/2016 Class II Dairy Farmers of America Inc. is recalling a number of cheese products due that a piece of plastic film strip might remain attached to the cheese slice upon peeling the film from the product. Dairy Farmers OF America Inc
Food Pasteurized Prepared Cheese Product: FOOD CLUB 12/12OZ SINGLES AMERICAN CHEESE PRODUCT YLW, 3680047752. BORDEN BL 12/6OZ AMER CHS PROD YLW, 6317500640 BORDEN 24/4.37 OZ AMER CHS PROD YLW, 5300000330. BORDEN 24/6.56OZ AMER CHS PROD YLW, 5300000350. BORDEN 12/13.12OZ AMER CHS PROD YLW 1, 5300000370. BORDEN 24/6OZ AMER CHS PROD YLW, 5300000566. BORDEN 12/12OZ HT AMER CHS PRODUCT COLOR(YLW), 5300000636. Sell By/Use By 8/10/2015 to 4/30/2016 Class II Dairy Farmers of America Inc. is recalling a number of cheese products due that a piece of plastic film strip might remain attached to the cheese slice upon peeling the film from the product. Dairy Farmers OF America Inc
Food Pasteurized Prepared Cheese Product: BORDEN 12/12OZ WHITE AMER CHEESE PROD , 5300001636. CUMBERLAND 12/8OZ AMER CHEESE PROD WHITE, 4270401171 Sell By/Use By 8/10/2015 to 4/30/2016 Class II Dairy Farmers of America Inc. is recalling a number of cheese products due that a piece of plastic film strip might remain attached to the cheese slice upon peeling the film from the product. Dairy Farmers OF America Inc
Food Pasteurized Prepared Cheese Product: .BORDEN 12/10.67OZ GRILLED CHEESE MELTS YLW PP2.99, 5300000429. BORDEN 12/12OZ GRILLED CHEESE MELTS YLW, 5300000436. BORDEN 48/12 OZ GRILLED CHEESE MELTS , 5300000436. Sell By/Use By 8/10/2015 to 4/30/2016 Class II Dairy Farmers of America Inc. is recalling a number of cheese products due that a piece of plastic film strip might remain attached to the cheese slice upon peeling the film from the product. Dairy Farmers OF America Inc
Food Pasteurized Prepared Cheese Product: BORDEN 12/8OZ SWISS SINGLES CHEESE PROD WHT, 5300000682. Sell By/Use By 8/10/2015 to 4/30/2016 Class II Dairy Farmers of America Inc. is recalling a number of cheese products due that a piece of plastic film strip might remain attached to the cheese slice upon peeling the film from the product. Dairy Farmers OF America Inc
Food Pasteurized Prepared Cheese Product: BORDEN 12/8OZ LACTOSE FREE AMER YLW, 5300000902. Sell By/Use By 8/10/2015 to 4/30/2016 Class II Dairy Farmers of America Inc. is recalling a number of cheese products due that a piece of plastic film strip might remain attached to the cheese slice upon peeling the film from the product. Dairy Farmers OF America Inc
Food Pasteurized Prepared Cheese Product: SENSATIONS 12/8OZ SOUTHWEST PEPPER JACK WHT, 5300000990. Sell By/Use By 8/10/2015 to 4/30/2016 Class II Dairy Farmers of America Inc. is recalling a number of cheese products due that a piece of plastic film strip might remain attached to the cheese slice upon peeling the film from the product. Dairy Farmers OF America Inc
Food Pasteurized Prepared Cheese Product: BORDEN 12/13.12OZ DTT AMERICAN CHEDDAR PROD, 45110155767.3 . Sell By/Use By 8/10/2015 to 4/30/2016 Class II Dairy Farmers of America Inc. is recalling a number of cheese products due that a piece of plastic film strip might remain attached to the cheese slice upon peeling the film from the product. Dairy Farmers OF America Inc
Food Pasteurized Prepared Cheese Product: FOOD CLUB 12/12 OZ CHEEZY DOES IT, PASTEURIZED PREPARED CHEESE PRODUCT, 3680032338. Sell By/Use By 8/10/2015 to 4/30/2016 Class II Dairy Farmers of America Inc. is recalling a number of cheese products due that a piece of plastic film strip might remain attached to the cheese slice upon peeling the film from the product. Dairy Farmers OF America Inc
Food Flavored Pasteurized Prepared Cheese Product: MEIJER 12/12OZ MONTEREY PEPPER JACK SINGLES PASTEURIZED PREPARED CHEESE PRODUCT,1928313223. Sell By/Use By 8/10/2015 to 4/30/2016 Class II Dairy Farmers of America Inc. is recalling a number of cheese products due that a piece of plastic film strip might remain attached to the cheese slice upon peeling the film from the product. Dairy Farmers OF America Inc
Food Flavored Pasteurized Prepared Cheese Product: COBURN FARMS 12/12OZ SINGLES PEPPER JACK WHT,.5193315780. Sell By/Use By 8/10/2015 to 4/30/2016 Class II Dairy Farmers of America Inc. is recalling a number of cheese products due that a piece of plastic film strip might remain attached to the cheese slice upon peeling the film from the product. Dairy Farmers OF America Inc
Food American Pasteurized Cheese Product: VALU TIME 12/12OZ AMERICAN SLICES CHEESE PRODUCT YLW, 1122502996. Sell By/Use By 8/10/2015 to 4/30/2016 Class II Dairy Farmers of America Inc. is recalling a number of cheese products due that a piece of plastic film strip might remain attached to the cheese slice upon peeling the film from the product. Dairy Farmers OF America Inc
Food Imitation Pasteurized Process Cheese Food: VALUE TIME 12/8OZ SANDWICH SLICES IMITATION PASTEURIZED PROCESS CHEESE FOOD, AMER IMIT YLW, 1122509140. VALUE TIME 12/10.67OZ SANDWICH SLICES IMITATION PASTEURIZED PROCESS CHEESE FOOD, AMER IMIT YLW, 1122558045. VALUE TIME 48/10.67OZ AMER IMIT YLW DS, 1122558045. CLEAR VALUE 48/10.67 OZ SANDWICH SLICES IMITATION PASTEURIZED PROC EES CHEESE FOOD AMER IMIT YLW, 3680012151. CLER VALUE 12/10.67OZ SANDWICH SLICES IMITATION PASTEURIZED PROCESS CHEESE FOOD ,AMER IMIT YLW, 3680012151. CLEAR VALUE 48/8OZ AMER IMIT YLW DS, 3680028619. LYNDER 36/10.67OZ IMITATION American singles, AMER IMIT YLW DS, 4149819363. FIESTA 36/16 SINGLES IMITATION PASTEURIZED PROCESS CHEESE FOOD AMER IMIT YLW DS, 5102240005. FIESTA 48/10.67OZ SINGLES, IMITATION PASTEURIZED PROCESS CHEESE FOOD AMER IMIT YLW DS, 5102240006. MCCLARYS 36/10.67OZ SINGLES AMERICAN SANDWICH SLICES, AMER IMIT YLW DS, 5193305332. S-MART 48/302 AMERICANO, AMER IMIT YLW DS, 6057110062. SANDWICH MATE 12/8OZ SINGLES, AMER IMIT PP.99 YLW, 7103025050. SANDWICH MATE 48/8OZ DS AMER IMIT PP.99 YLW, 7103025050. SANDWICH MATE 12/8OZ AMER IMIT PP1.29 YLW, 7103025052. SANDWICH MATE 48/8OZ AMER IMIT PP1.29 YLW DS, 7103025052. SANDWICH MATE 12/10.67OZ AMER IMIT YLW, 7103025162. SANDWICH MATE 12/8.75 OZ AMER IMIT YLW, 7103025253. SANDWICH MATE 12/8OZ AMER IMIT YLW, 7103025260. SANDWICH MATE 36/4.37 OZ AMER IMT YLW, 710302526.8 FISHER 36/10.67OZ SANDWICH SLICES IMITATION PASTEURIZED PROCESS CHEESE FOOD AMER IMIT YLW DS, 7103025278. SANDWICH MATE 24/6.56OZ AMER IMT YLW, 7103025288. Sell By/Use By 8/10/2015 to 4/30/2016 Class II Dairy Farmers of America Inc. is recalling a number of cheese products due that a piece of plastic film strip might remain attached to the cheese slice upon peeling the film from the product. Dairy Farmers OF America Inc
Food Imitation Pasteurized Process Cheese Food: BORDEN SUCREM 12/16.4OZ SANDWICH SLICES, AMER IMIT, 451101550735. COUNTRY FARE 12/10.67OZ AMERICAN SANDWICH SLICES, IMIT SINGLE, 7545089000 Sell By/Use By 8/10/2015 to 4/30/2016 Class II Dairy Farmers of America Inc. is recalling a number of cheese products due that a piece of plastic film strip might remain attached to the cheese slice upon peeling the film from the product. Dairy Farmers OF America Inc
Food Imitation Pasteurized Process Cheese Food: SANDWICH MATE 12/10.67OZ SINGLES, SWISS IMIT WHT, 7103025172. VALU TIME 12/10.67OZ SWISS Flavored sandwich slices, IMIT WHT, 1122502481. Sandwich MATE 12/8OZ SWISS flavor singles, IMIT PP.99 WHT, 7103025175 Sell By/Use By 8/10/2015 to 4/30/2016 Class II Dairy Farmers of America Inc. is recalling a number of cheese products due that a piece of plastic film strip might remain attached to the cheese slice upon peeling the film from the product. Dairy Farmers OF America Inc
Food Imitation Pasteurized Process Cheese Food: . Sandwich MATE 12/10.67OZ Monterey JACK singles, IMIT WHT. 7103025182. Sandwich MATE 12/8OZ Monterey JACK singles, IMIT PP.99 WHT, 7103025185 Sell By/Use By 8/10/2015 to 4/30/2016 Class II Dairy Farmers of America Inc. is recalling a number of cheese products due that a piece of plastic film strip might remain attached to the cheese slice upon peeling the film from the product. Dairy Farmers OF America Inc
Food Fat Free Pasteurized Prepared Cheese Product: BORDEN 12/12OZ SHARP CHEDDAR FAT FREE YLW, 5300000678. Sell By/Use By 8/10/2015 to 4/30/2016 Class II Dairy Farmers of America Inc. is recalling a number of cheese products due that a piece of plastic film strip might remain attached to the cheese slice upon peeling the film from the product. Dairy Farmers OF America Inc
Food Fat Free Pasteurized Prepared Cheese Product: ESSENTIAL EVERYDAY 12/10.7OZ SINGLES WHITE AMERICAN, FF IWS AMER PROC WHT, 4130300848. BORDEN 12/12OZ AMERICAN FAT FREE WHT, 5300001675. Sell By/Use By 8/10/2015 to 4/30/2016 Class II Dairy Farmers of America Inc. is recalling a number of cheese products due that a piece of plastic film strip might remain attached to the cheese slice upon peeling the film from the product. Dairy Farmers OF America Inc
Food Fat Free Pasteurized Prepared Cheese Product: HYVEE 12/12OZ FAT FREE SWISS CHS, 7545009327. BORDEN 12/12OZ SWISS FAT FREE WHT, 5300000679. Sell By/Use By 8/10/2015 to 4/30/2016 Class II Dairy Farmers of America Inc. is recalling a number of cheese products due that a piece of plastic film strip might remain attached to the cheese slice upon peeling the film from the product. Dairy Farmers OF America Inc
Food Fat Free Pasteurized Prepared Cheese Product: BORDEN 12/12OZ FF PEPPER JACK WHT, 5300000680.. Sell By/Use By 8/10/2015 to 4/30/2016 Class II Dairy Farmers of America Inc. is recalling a number of cheese products due that a piece of plastic film strip might remain attached to the cheese slice upon peeling the film from the product. Dairy Farmers OF America Inc
Devices OxySure Model 615 disposable replacement cartridges lots 61-65 Class II Flow rate of the recalled replacement cartridges does not meet the draft FDA standard of a minimum 6 LPM for a minimum of 15 minutes. Oxysure Systems, Inc.
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W038215032685 (2 units) Class III Blood products, which were labeled with an incorrect volume and incorrect platelet yield, were distributed. Kentucky Blood Center Inc
Biologics Platelets Pheresis Leukocytes Reduced W038215032685 Class III Blood products, which were labeled with an incorrect volume and incorrect platelet yield, were distributed. Kentucky Blood Center Inc
Devices Invivo Expression MRI Patient Monitoring System. Model Number 865214 (Invivo Expression MRI Patient Monitoring System) Devices with the FlexTEMP reusable temperature option installed (serial number range US31204918 through US42708744). Please note that not every serial number within the listed range has the temperature option. Devices without the temperature option are not affected by this Medical Device  ...
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Class II The device's labeling inaccurately indicates "endotracheal" as a body temperature application site. The FlexTEMP reusable temperature sensor is not intended to be used for endotracheal placement. The application site should be listed as ¿esophageal¿. Philips Electronics North America Corporation
Biologics Whole Blood Leukocytes Reduced W1170150148515; Class II Blood product, in which quality control and distribution of product did not meet specifications, was distributed. Blood Centers of the Pacific - Irwin Center
Biologics Blood and Blood Products for Reprocessing 6633056; Class II Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. Belle Bonfils Memorial Blood Center
Devices Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Product Usage: The Breath Alcohol Detector is for the semi-quantitative rapid detection of the presence of alcohol in the exhaled breath. The Breath Alcohol Detector indicated relative Blood Alcohol Concentration (BAC) at 0.02%, 0.04%, 0.05%, 0.06%, 0.08%, or 0.10% cut-off levels. -BAD4040003 (48 kits) -BAD4080006 (59 kits) -BAD5010010/BAD5040013/BAD5010011 (total of 1,176 kits) Class III Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment. Acon Laboratories, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W333415000777; Class III Blood product, for which the quality control testing was incomplete, was distributed. Mississippi Valley Reg Bld Ctr
Devices Cortical Pin 2.0 mm,Sterile, FREEZE DRIED: Store at ambient temperature. Do Not freeze. Lot #06512078901017, Item #400920. The tissue is placed in a retainer and sealed in a blister pack Class II Musculoskeletal Transplant Foundation (MTF) is recalling one lot of MTF's Allograft Cortical Pins because the lot was labeled as a 2.0 mm diameter pin and it may contain a 2.4 mm diameter pin. Musculoskeletal Transplant Foundation, Inc.
Devices Paragon Laboratory Management Model 12.1 and 12.1.1 Class II For Paragon Laboratory Management 12.1 and 12.1.1 releases, if used with Microsoft SQL Server 2012, the Final Cumulative Report may incorrectly display the data. McKesson Technologies, Inc.
Devices Potential missing segments on the display that can result in misinterpretation of data. All Lots of Product Code N650, N65, N65-1, N65P, N65P-1 Class II Covidien LP is recalling Nellcor OxiMa N-65 Handheld Pulse Oximeter and Nellcor OxiMax N-65 Handheld Pulse Oximeter because of potential missing segments on the display that can result in misinterpretation of data. Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Devices Potential missing segments on the display that can result in misinterpretation of data. All Lots, Product code N560 Class II Covidien LP is recalling Nellcor OxiMa N-65 Handheld Pulse Oximeter and Nellcor OxiMax N-65 Handheld Pulse Oximeter because of potential missing segments on the display that can result in misinterpretation of data. Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Food goodies by Nature RAW CASHEWS, NET WT. 9 oz (255g), held in clear plastic tubs, UPC code of 846034010055. Distributed By: Grand BK Corp. 47-08 Grand Ave. Maspeth, NY 11378. Product of India. SELL BY 042916 & 050216 Class I Grand BK Corp. recalls Goodies By Nature RAW CASHWES due to Salmonella contamination. GRAND BK CORP.
Biologics Source Plasma AB1458829; Class III Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed. DCI Biologicals LLC
Devices Fabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine for use in MRI environments in operating, induction and recovery rooms. Catalog Number(s): 8607300 Class II the Fabius MRI or parts of the system were attracted by the magnetic field of the MRI. If the Fabius MRI is positioned too close to the MRI, its parts can be loosened as a result of the magnetic force of the MRI. Draeger Medical, Inc.
Devices Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/R. The Synthes Matrix ORTHOGNATHIC Fixation System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla, mandible and chin in adults and children. Part Numbers: 04.511.381 04.511.382 Lot Numbers: 8672528 8673158 & 8672260 Class II The affected part and lot numbers of the TI Matrix Pre-Bent Maxillary Plates may potentially have the incorrect laser etch denoting the orientation. Synthes (USA) Products LLC
Food Atkins Chocolate Candies  5 ct. cartons - UPC code 637480075558 Atkins Chocolate Candies, 5 ct. - Cartons, UPC Code 637480075558, Lot Numbers: A5118139439C; A5119139439A, B, C ; A5120139439A; Best Before Date: April 28 2016, April 29, 2016, April 30, 2016 Class II Atkins Nutritionals, Inc. is initiating a voluntary recall of a limited quantity of Atkins Chocolate Candies because it may contain sachets of Atkins Peanut Candies. Atkins Indiana Distribution Center
Food Atkins Chocolate Peanut Candies 5 ct. Case - UPC code 637480075770 Atkins Chocolate Peanut Candies, 5 ct. - Case, UPC Code 637480075770, Lot Numbers: A5118139439C; A5119139439A, B, C ; A5120139439A; Best Before Date: April 28 2016, April 29, 2016, April 30, 2016 Class II Atkins Nutritionals, Inc. is initiating a voluntary recall of Cases of Atkins Chocolate Peanut Candies because it may contain Atkins Chocolate Candies that have sachets of Atkins Peanut Candies. Atkins Indiana Distribution Center
Devices Hardy Diagnostics MacConkey Agar with CiPRP, 1ug/ml Container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: MacConkey Agar with Ciprofloxacin is used as a screening medium for the selective isolation of Ciprofloxacin-resistant E. coli from clinical samples. Lot number: 15096 and 15107 Class II Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance. Hardy Diagnostics
Devices Hardy Diagnostics BHI with CIPRO, 1ug/ml container type: 16x100mm tube packaged: 20 tubes/box Product Usage: Brain Heart Infusion Broth with Ciprofloxacin, 1ug is for use as pre-enrichment broth for the cultivation of ciprofloxacin-resistant organisms from clinical samples. Lot number: 15055, 15083, and 15091 Class II Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance. Hardy Diagnostics
Devices Hardy Diagnostics MDR Acinetobacter container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: MDR Acinetobacter is for the primary selective screening for detection and differentiation of multi-drug resistant (MDR) Acinetobacter baumannii. Lot number: 15092, 15101, 15113 Cat no. G259 Class II Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance. Hardy Diagnostics
Devices Hardy Diagnostics BEA Agar with Vancomycin container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: BEA (Bile Esculin Agar) with Azide and Vancomycin for VRE is used as a direct screening medium in the isolation and presumptive identification of vancomycin-resistant enterococci/group D streptococci, such as Enterococcus faecalis and E. faecium, from fecal and rectal cultures. Lot number: 15075. 15096, 15107, 15121, 15134, and 15154 Cat no. G103 Class II Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance. Hardy Diagnostics
Devices Hardy Diagnostics BEA Agar with VGA container type: 15x100mm monoplate packaged: 10 places/sleeve Product Usage: BEA (Bile Esculin Azide) Agar with Vacomycin, Gentamicin, and Amphotericin B is for the selective isolation of vancomycin resistant enterococci (VRE). Lot number: 15105 Cat no. G107 Class II Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance. Hardy Diagnostics
Devices Hardy Diagnostics BEA Broth with Vancomycin container type: 13x100mm tube packaged: 20 tubes/box fill: 2ml Product Usage: BEA (Bile Esculin Azide) Broth with Vancomycin is for the surveillance of vancomycin resistant enterococci (VRE) not to be used for susceptibility reporting Lot number: 15070 Cat no. R98 Lot number: 14193, 14232, 14251, 14272, and 14329 Cat no.: R72 Class II Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance. Hardy Diagnostics
Devices Hardy Diagnostics VRE Broth, 5ml container type: 16x100mm tube packaged: 20 tubes/box fill: 5ml Product Usage: BEA (Bile Esculin Azide) Broth with Vancomycin is for the surveillance of vancomycin resistant enterococci (VRE) not to be used for susceptibility reporting. Lot number: 15021, 15043, 15072, 15126, 15152 Cat no. K103 Class II Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance. Hardy Diagnostics
Devices Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument. Lots: DB0114069, DB0114349, CA46096, CA216052, DB0111264001, DB0112016, DB0113102. Class II Tornier has initiated a voluntary recall for the Aequalis® IM Nail instrumentation set (Tray Number 9020000) due to several reports that the mast of the targeting jig (Part Number 9020060) is separating from the jigs boom. Any separation will impact alignment and can affect the ability to fixate Aequalis® IM Nail screws. Tornier, Inc
Devices Medical Device Exchange Surgical Gown - Flyte Hood Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 408-800 EXP (repackager) Stryker (OEM) Person protection during surgery. OEM Catalog number 408-800; Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Devices Medical Device Exchange - GelPort Laparoscopic System; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number C8XX2N0NCE. EXP (repackager), Applied Medical (OEM) Laparoscope, General & Plastic Surgery. OEM Catalog number C8XX2N0NCE. Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Devices Medical Device Exchange - KII FIOS FIRST ENTRY 5X100MM; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number CFF03 EXP (repackager), Applied Medical (OEM) Laparoscope, General & Plastic Surgery. OEM Catalog number CFF03. Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Devices Medical Device Exchange - 5.5mm BioComposite Corkscrew FT, Vented Suture Anchor; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number AR-1927BCF; EXP (repackager), Arthrex (OEM) Fastener, fixation, nondegradable, soft tissue OEM Catalog number AR-1927BCF. Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Devices Medical Device Exchange - Trocar VersaPort Plus V2; 5mm -11mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 179095P; EXP (repackager), Auto Suture (OEM) Laparoscope, General and Plastic Surgery OEM Catalog number 179095P. Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Devices Medical Device Exchange - Endo Catch 10mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 173050G; EXP (repackager), Auto Suture (OEM) Endoscope and Accessories OEM Catalog number 173050G. Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Devices Medical Device Exchange - GIA Auto Suture Loading Unit w/ DST Series Technology 80mm - 4.8mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number GIA8048L; EXP (repackager), Covidien (OEM) Implantable Staple OEM Catalog number GIA8048L. Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Devices Medical Device Exchange - Versaport Bladeless Trocar w/ Fixation Cannula 5mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number NB5STF; EXP (repackager), Covidien (OEM) Laparoscope, General & Plastic Surgery OEM Catalog number NB5STF. Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Devices Medical Device Exchange - Loading Unit w/ DST Series Technology 60mm - 3.5mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number TA6035L; EXP (repackager), Covidien (OEM) Implantable Staple OEM Catalog number TA6035L. Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Devices Medical Device Exchange - Dilating Tip Trocar w/Stability Sleeve 11mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number D11LT; EXP (repackager), Ethicon (OEM) Laparoscope, General & Plastic Surgery OEM Catalog number D11LT. Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Devices Medical Device Exchange - Dilating Tip Trocar w/Stability Sleeve 12mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number D12LT; EXP (repackager), Ethicon (OEM) Laparoscope, General & Plastic Surgery OEM Catalog number D12LT. Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Devices Medical Device Exchange - Mayfield Disposable Skull Pin; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number A1072; EXP (repackager), Integra (OEM) Holder, head, neurosurgical (skull clamp) OEM Catalog number A1072. Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Devices Medical Device Exchange - Silicone Round Drain; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number SU130-1321; EXP (repackager), Jackson Pratt (OEM) Apparatus, suction, single patient use, portable, nonpowered OEM Catalog number SU130-1321. Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Devices Medical Device Exchange - Auto Suture Endo Universal 65° 4mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 173054; EXP (repackager), Tyco (OEM) Laparoscope, General & Plastic Surgery OEM Catalog number 173054. Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Devices Medical Device Exchange -Suction Coagulator; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number E2505-10FR; EXP (repackager), Valleylab (OEM) Electrosurgical, cutting & coagulation & accessories OEM Catalog number E2505-10FR. Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Devices Medical Device Exchange -APPLIER, MULTICLIP ROTATING; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 3299; EXP (repackager), Covidien (OEM) Clip, implantable OEM Catalog number 3299. Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Devices Medical Device Exchange -SYSTEM, TACKER SKIN 5MM; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 6206; EXP (repackager), Covidien (OEM) Implantable Staple OEM Catalog number 6206. Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Devices Medical Device Exchange BAG, SPECIMEN RETRIEVER ENDO; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 2444; EXP (repackager), Covidien (OEM) Specimen retriever bag. OEM Catalog number 2444. Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Devices Medical Device Exchange ETS FLEX 45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45MM STAPLE; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number ATS45; EXP (repackager), Ethicon (OEM) Implantable Staple. OEM Catalog number ATS45. Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Devices Medical Device Exchange FIBERWIRE SUTURE SCISSOR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number AR-11796; EXP (repackager), Arrow (OEM) Electrosurgical, cutting & coagulation & accessories. OEM Catalog number AR-11796. Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Devices Medical Device Exchange FEMORAL CANAL TIP; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 210-8-N; EXP (repackager), Stryker (OEM) Lavage, jet OEM Catalog number 210-8-N. Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Devices Medical Device Exchange Insufflation Needle; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number C2201; EXP (repackager), Medline (OEM) Insufflator, laparoscopic OEM Catalog number C2201. Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Devices Medical Device Exchange 10MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 9-AVP2-010; EXP (repackager), Aga Medical (OEM) Transcatheter septal occluder OEM Catalog number 9-AVP2-010. Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Devices Medical Device Exchange 12MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 9-AVP2-012; EXP (repackager), Aga Medical (OEM) Transcatheter septal occluder OEM Catalog number 9-AVP2-012. Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Devices Medical Device Exchange PT WIRE 300; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 38931-04; EXP (repackager), Boston Scientific (OEM) Wire, guide, catheter OEM Catalog number 38931-04. Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Devices Medical Device Exchange X-SAW BLADE; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5059-531; EXP (repackager), Linvatic Corp (OEM) Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment OEM Catalog number 5059-531. Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Devices Medical Device Exchange Wire (sternotomy wire); Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 046-072; 046-073; EXP (repackager), A & E Medical (OEM) Suture, nonabsorbable OEM Catalog number 046-072; 046-073. Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Devices Medical Device Exchange Round Fluted Bur Soft Touch; 2.0mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-120; EXP (repackager), Stryker (OEM) Drills, burrs, trephines & accessories (simple, powered) OEM Catalog number 5820-10-120. Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Devices Medical Device Exchange Round Diamond Bur Extra Coarse; 3.0mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-130; EXP (repackager), Stryker (OEM) Drills, burrs, trephines & accessories (simple, powered) OEM Catalog number 5820-10-130. Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Devices Medical Device Exchange 6.0mm Round Fluted Bur Soft Touch; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-160; EXP (repackager), Stryker (OEM) Drills, burrs, trephines & accessories (simple, powered) OEM Catalog number 5820-10-160. Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Devices Medical Device Exchange Round Fluted Bur Aggressive; 4.0mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-240; EXP (repackager), Stryker (OEM) Drills, burrs, trephines & accessories (simple, powered) OEM Catalog number 5820-10-240. Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Devices Medical Device Exchange PhysioMesh Flexible Composite Mesh 10cm x 15cm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number PHY1015V; EXP (repackager), Ethicon (OEM) Mesh, surgical, polymeric OEM Catalog number PHY1015V. Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Devices Medical Device Exchange PhysioMesh Flexible Composite Mesh 15 x 15cm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number PHY1515Q; EXP (repackager), Ethicon (OEM) Mesh, surgical, polymeric OEM Catalog numberPHY1515Q. Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Devices Medical Device Exchange SECURESTRAP 5mm Absorbable Strap Fixation Device; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number STRAP25; EXP (repackager), Ethicon (OEM) Strap, implantable. OEM Catalog number STRAP25. Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Devices Medical Device Exchange TAUT Intraducer Peritoneal Catheter 2mm x 1.6mm x 7.6cm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number PI-63; EXP (repackager), Teleflex (OEM) Catheter, biliary, surgical OEM Catalog number PI-63. Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Devices Medical Device Exchange 3.5mm Threaded Cerclage Pin; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 298.838S; EXP (repackager), Synthes (OEM) Cerclage, fixation OEM Catalog number 298.838S. Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Devices Medical Device Exchange 2.15MMX22MM Fluted Spiral Router for CRANI-A; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number A-CRN-S; EXP (repackager), Anspach (OEM) Bur, surgical, general & plastic surgery OEM Catalog number A-CRN-S. Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Devices Medical Device Exchange 12x40 Airway Stent System; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 90129-212; EXP (repackager), Aero (OEM) Prosthesis, tracheal, expandable OEM Catalog number 90129-212. Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Devices Medical Device Exchange 10x40 Airway Stent System; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 90129-209; EXP (repackager), Aero (OEM) Prosthesis, tracheal, expandable OEM Catalog number 90129-209. Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Devices Medical Device Exchange Angio-Seal VIP Platform/Vascular Closure Device 6F; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 610130. EXP (repackager), St. Jude Medical (OEM) Device, hemostasis, vascular OEM Catalog number 610130. Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Devices Medical Device Exchange Chocolate Balloon Catheter/Over-the-Wire; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number CF14-150-25040-OTW. EXP (repackager), TriReme Medical (OEM) Catheter, angioplasty, peripheral, transluminal OEM Catalog number CF14-150-25040-OTW. Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Devices Medical Device Exchange Aerosizer Stent Sizing Device; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 90129-501. EXP (repackager), Merit Medical (OEM) Prosthesis, tracheal, expandable OEM Catalog number 90129-501. Class II EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. EXP Pharmaceutical Services Corp
Biologics Platelets Pheresis Leukocytes Reduced W311215600612; Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Atlanta Blood Services
Biologics Red Blood Cells Leukocytes Reduced W137514211271; W137515201652; Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Lane Memorial Blood Bank
Devices IPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number 609432AN, Rx only. Porcelain glaze spray used in the fabrication of dental restorations. Batch U15124 Class II A number of complaints were received with the issue of coarse particles in the glazed surface of IPS e.max Ceram restorations. An analysis of the production process revealed that a basic component of the glass contains a higher number of large grain sizes than usual. Ivoclar Vivadent, Inc.
Food Vegetable Chili, 8 oz plastic container, labeled with a green and white label with green and white lettering. lot number: 70915 The lot code is also the expiration date of the product. (7/9/2015) Class I The Vegetable Chili contains undeclared milk, an allergen. Brett Anthony Foods
Devices FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139 Lot 53839799 and 414012 Class II All the engraved markings on the distal face of the instruments are mis-oriented by 180°. This includes the markings Anterior and Posterior which the surgeon would use to correctly place the cut block on the resectioned face of the femur. The cut block is not symmetric, so correct orientation of the instrument in the anterior/posterior direction is critical to making the proper anterior, posterior, and chamfer cuts to accommodate the femoral implant. Encore Medical, Lp
Biologics Phoma destructiva 216021814 Class III Misbranded Allergenic Extracts were distributed. Allergy Laboratories, Inc.
Biologics Nigrospora sphaerica 212061014; Class III Misbranded Allergenic Extracts were distributed. Allergy Laboratories, Inc.
Biologics Rhodotorula sp. 218100713; Class III Misbranded Allergenic Extracts were distributed. Allergy Laboratories, Inc.
Biologics Bermuda Grass Smut 240080912; Class III Misbranded Allergenic Extracts were distributed. Allergy Laboratories, Inc.
Biologics Hormodendrum (Cladosporium) 202071414; Class III Misbranded Allergenic Extracts were distributed. Allergy Laboratories, Inc.
Biologics Mouse Hair 305052114; Class III Misbranded Allergenic Extracts were distributed. Allergy Laboratories, Inc.
Biologics Oak, Virginia Live 051100113; Class III Misbranded Allergenic Extracts were distributed. Allergy Laboratories, Inc.
Biologics Rhizopus nigricans 217050714; Class III Misbranded Allergenic Extracts were distributed. Allergy Laboratories, Inc.
Biologics Horse Hair 302042814; Class III Misbranded Allergenic Extracts were distributed. Allergy Laboratories, Inc.
Biologics Cocklebur 123013013; Class III Misbranded Allergenic Extracts were distributed. Allergy Laboratories, Inc.
Biologics Hickory, White 036040912; Class III Misbranded Allergenic Extracts were distributed. Allergy Laboratories, Inc.
Biologics Bahia Grass 081071414; Class III Misbranded Allergenic Extracts were distributed. Allergy Laboratories, Inc.
Biologics Cottonwood, Western 020040114; Class III Misbranded Allergenic Extracts were distributed. Allergy Laboratories, Inc.
Biologics Oak, White 078031114; Class III Misbranded Allergenic Extracts were distributed. Allergy Laboratories, Inc.
Biologics Mucor racemosus 209060414; Class III Misbranded Allergenic Extracts were distributed. Allergy Laboratories, Inc.
Biologics Stemphylium sarciniforme 230092313 Class III Misbranded Allergenic Extracts were distributed. Allergy Laboratories, Inc.
Biologics Oak, Mix 053032513; Class III Misbranded Allergenic Extracts were distributed. Allergy Laboratories, Inc.
Biologics Non Standardized Allergenics 2300923413; 043110612; 296041614; Class III Misbranded Allergenic Extracts were distributed. Allergy Laboratories, Inc.
Biologics Oats, Common, Cultivated 418092513; Class III Misbranded Allergenic Extracts were distributed. Allergy Laboratories, Inc.
Biologics Soybean 348120313; Class III Misbranded Allergenic Extracts were distributed. Allergy Laboratories, Inc.
Biologics Egg, Whole 390120913; Class III Misbranded Allergenic Extracts were distributed. Allergy Laboratories, Inc.
Biologics Tomato 466051914; Class III Misbranded Allergenic Extracts were distributed. Allergy Laboratories, Inc.
Biologics Potato, White 445060412; Class III Misbranded Allergenic Extracts were distributed. Allergy Laboratories, Inc.
Biologics Beef 350021213; Class III Misbranded Allergenic Extracts were distributed. Allergy Laboratories, Inc.
Biologics Coffee 380091913; Class III Misbranded Allergenic Extracts were distributed. Allergy Laboratories, Inc.
Drugs Clonidine Hydrochloride Tablets, USP, 0.1 mg, packaged in a) 100 count (NDC 53489-215-01) and b) 1000 count (NDC 53489-215-10) HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA Lot #: a) 6624001 exp 2/16, 6630501 exp 3/16, 6669001 exp 12/16, 6676201 exp 1/17, 6680701 exp 2/17; b) 6624002, 6624201 exp 2/16, 6630601 exp 3/16, 6668901 exp 12/16, 6676001, 6676101 exp 1/17, 6679401, 6679501, exp 2/17. Class II cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer Mutual Pharmaceutical Company, Inc.
Drugs Clonidine Hydrochloride Tablets, USP, 0.2 mg, 100 count (NDC 53489-216-01) and 1000 count (NDC 53489-216-10) HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA. PACKAGED LOT#s: 100 count (NDC 53489-216-01); 6643901, exp 5/16, 6677201, exp 1/17 1000 count (NDC 53489-216-10); 6677101, EXP 1/17 Class II cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer Mutual Pharmaceutical Company, Inc.
Drugs Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100 count HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA, NDC 53489-217-01. Lot #: 6676701 and 6676801, exp 1/17. Class II cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer Mutual Pharmaceutical Company, Inc.
Devices ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. Model numbers: 10041461, 10440017  S2000 system 10441730  S3000 system 10441701  S1000 system; software version VC30A, VC30B, VC30C, or VC31A; Serial numbers US: 210104 210121 210187 211161 210103 206479 206595 206701 206726 200313 200394 207073 207099 210186 210811 211030 211147 211148 211477 212130 210509 210510 210540 210702 210714  ...
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Class II Potential measurement error on ACUSON S Family ultrasound system when using the Doppler manual trace measurement tool in full screen format that has a low probability of misdiagnosis. Siemens Medical Solutions USA, Inc.
Devices ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. Model numbers: 10041461, 10440017 - S2000 system; 10441730 - S3000 system; VTIQ Option - 10439521 and 10439522. Serial numbers for US: 210104 211147 211148 210257 211071 201387 201389 206511 206574 206592 206619 206732 206832 208718 208772 210931 211483 212156 212157 202555 210055 210061 210423 210426 210427 210629 206049 210032 210128  ...
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Class II Potential measurement error on your ACUSON S Family ultrasound system when repositioning the Virtual Touch IQ region of interest from the original (default) location, the lateral position of the measurement tool may not align with the lateral position. of the shear velocity data Siemens Medical Solutions USA, Inc.
Devices Ottobock Pheon 3R62 Knee Joint The 3R62 Pheon is a polycentric prosthetic knee joint intended to be used solely for lower limb prosthetic fittings. It is available in several versions to allow attachment to other components based on the patient need and physiology. The removal affects all devices manufactured and distributed since February 2014. Class II Otto Bock Healthcare GmbH is voluntarily recalling all 3R62 Pheon polycentric prosthetic knee joints distributed since February 2014 because the locking function may fail under certain conditions which may result in a fall. Otto Bock Healthcare GmbH
Food RACHAEL'S GOURMET Candy Necklaces, Net Wt. 1.95 oz.; UPC: 0-77449-50452-9 1-20-16, 2-6-16, 3-3-16, 4-30-16, 08-17-16, 08-18-16, 10-8-16, 10-9-16, 12-29-16, 4-15-17 Class III The product contains undeclared FD&C Blue #1, FD&C Red #40, and FD&C Yellow #5. In addition, FD&C Blue # 2 is declared on the label but was not found in the product. Consumer Product Distributors Inc. dba J Polep Distributif
Biologics Blood Grouping Reagent, Anti-D (Monoclonal IgG Blend) (Formulated for Automated Testing) 841611001; Class III Anti-D Blend Solidscreen II, containg a weak reacting contaminating anitbody, was distributed. Bio-Rad Medical Diagnostics GmbH
Biologics Fescue, Meadow F09021213; Class III Allergenic Extract, associated with an out of specification stability result for potency, was distributed. Antigen Laboratories Inc
Biologics Cornea NY1505004R1; NY1505004L1; Class III Human corneas, not tested adequately and appropriately to reduce the risk of transmission of relevant communicable diseases, were distributed. Sight Society Of Northeastern New York Lions Eye Bank@Albany
Drugs COMBIVENT RESPIMAT (ipratropium bromide and albuterol) Inhalation Spray, 20 mcg/100 mcg per actuation*, 4 Grams, 120 Metered Doses per inhaler, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Made in Germany, NDC 0597-0024-02. Lot #: 408267, Exp 11/17 Class II Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray. Boehringer Ingelheim Roxane Inc
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