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U.S. Department of Health and Human Services

Enforcement Report - Week of June 11, 2014

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Devices LifeCare 5000 Pump (Plum 1.6) infusion pump, indicated for volumetric infusion of critical drugs and fluids by intravenous (I.V.) administration. List Number: 02507; Serial Numbers: All. Class II There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of infusers to break. In the event of a broken door roller pin, the door cannot appropriately lock the cassette in the right position. Depending on the conditions of a broken door roller pin, a number of events can occur. The door cannot be closed or a cassette/door alarm or a false occlusion alarm might be triggered. Broken door roller pins can also cause the cassette door to be very loosely seated and, when jostled, may come out of position and stop infusion in the middle of therapy. And lastly, when the cassette door is opened, the cassette door mechanism may not fully clamp the IV tubing. Hospira Inc.
Devices Plum XL, Micro Macro Plum XL3 with data port, and Micro Macro Plum XL with data port infusion pumps, indicated for intravenous, arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to patients in hospital and home care environments. List Number: 11555; Serial Numbers: All. List Number: 11855; Serial Numbers: All. List Number: 11859; Serial Numbers: All. Class II There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of infusers to break. In the event of a broken door roller pin, the door cannot appropriately lock the cassette in the right position. Depending on the conditions of a broken door roller pin, a number of events can occur. The door cannot be closed or a cassette/door alarm or a false occlusion alarm might be triggered. Broken door roller pins can also cause the cassette door to be very loosely seated and, when jostled, may come out of position and stop infusion in the middle of therapy. And lastly, when the cassette door is opened, the cassette door mechanism may not fully clamp the IV tubing. Hospira Inc.
Devices Plum XL3 Multi line Infusion System, Micro Macro Plum XL3 Multi line Infusion System, and Micro Macro Plum XL Infusion System. Infusion pumps for intravenous. arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to patients in hospital and home care environments. List Number: 11781; Serial Numbers: All. List Number: 11845; Serial Numbers: All. List Number: 11846; Serial Numbers: All. Class II There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of infusers to break. In the event of a broken door roller pin, the door cannot appropriately lock the cassette in the right position. Depending on the conditions of a broken door roller pin, a number of events can occur. The door cannot be closed or a cassette/door alarm or a false occlusion alarm might be triggered. Broken door roller pins can also cause the cassette door to be very loosely seated and, when jostled, may come out of position and stop infusion in the middle of therapy. And lastly, when the cassette door is opened, the cassette door mechanism may not fully clamp the IV tubing. Hospira Inc.
Drugs GREENSTONE BRAND fluconazole for Oral Suspension, ORANGE FLAVORED, 40 mg/mL, when reconstituted, Rx only, Distributed by Greenstone LLC Peapack, NJ 07977. MADE IN INDIA. NDC 59762-5030-1 Lot # A358502; Exp 01/15 Class II Defective Container: Tamper evident ring failures discovered on some bottles. Pfizer Inc.
Cosmetics KISS MY Face Grapefruit & Bergamot Foaming Soap: 1) Net Wt. 8.75 Fl Oz (258 mL), UPC 0 28367 83309 3; 2) Net Wt. 17.5 Fl Oz (516 mL), UPC 0 28367 83479 3. Distributed by Kiss My Face LLC, Gardiner, NY 12525, Made in USA. Lot numbers: 1) K102512, K020513, K032113, K050913, K100213, K011414; 2) K122012, K011613, K032213, K041613, K051013, K091613, K100113 Class II Kiss My Face, LLC has recalled various foaming hand soap products due to Pseudomonas aeruginosa/fluorescens contamination. Kiss My Face
Cosmetics KISS MY Face Lemon & Ginger Foaming Soap: 1) Net Wt. 8.75 Fl Oz (258 mL) - UPC 0 28367 83473 1, 2) Net Wt. 17.5 Fl Oz (516 mL) - UPC 028367 834779. Distributed by Kiss My Face LLC, Gardiner, NY 12525, Made in USA. Lot numbers: 1) K110112, K031913, K031813, K071513, K011314; 2) K122112, K011713, K031913, K071613, K081613, K012114 Class II Kiss My Face, LLC has recalled various foaming hand soap products due to Pseudomonas aeruginosa/fluorescens contamination. Kiss My Face
Cosmetics KISS MY Face Lavender & Chamomile Foaming Soap: 1) Net Wt. 8.75 Fl Oz, UPC 0 28367 83308 6; 2) Net Wt. 17.5 Fl Oz (516 mL), 028367 834786. Distributed by Kiss My Face LLC, Gardiner, NY 12525, Made in USA. Lot numbers: 1) K110212, K032013, K050613, K081513, K092513; 2) K031913, K050613, K092613 Class II Kiss My Face, LLC has recalled various foaming hand soap products due to Pseudomonas aeruginosa/fluorescens contamination. Kiss My Face
Cosmetics KISS MY Face obsessively natural KIDS Self-Foaming Hand Wash, orange U smart, Net Wt. 8 Fl Oz (236 mL), UPC 0 28367 83591 2. Distributed by Kiss My Face LLC, Gardiner, NY 12525, Made in USA. Lot numbers: K121112, K032513, K050813, K011514, K021014 Class II Kiss My Face, LLC has recalled various foaming hand soap products due to Pseudomonas aeruginosa/fluorescens contamination. Kiss My Face
Biologics Platelets Pooled Leukocytes Reduced W037914556888; Class II Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. LifeServe Blood Center
Biologics Red Blood Cells Leukocytes Reduced W036513123097 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. LifeShare Blood Centers
Biologics Red Blood Cells Leukocytes Reduced W037914120526 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. LifeServe Blood Center
Devices ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery. ExacTrac software version 5.5.5 is included in the following model / catalog numbers: 1) 20818B ET SOFTWARE 5.  ...
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Class II When using a specific plan update workflow in combination with a non-Brainlab treatment planning system (TPS), there is a possibility in ExacTrac 5.5.5 to generate an unintended blend of two initially separate plans of the same patient. Brainlab AG
Biologics Red Blood Cells 2365399 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Fresh Frozen Plasma 2365399 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Platelets Pooled Leukocytes Reduced 2906908 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Devices Siemens SOMATOM Emotion 16 and SOMATOM Spirit Computed Tomography Systems Product Usage: To produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. Material numbers: 10165977, 10045692 with serial numbers: 32187 31158 31215 31222 31313 31354 32118 32120 32123 32125 32126 32127 32129 32139 32141 32156 32159 Class II The rubber damper may degrade and break, causing loosening of the motor mounting plates, which could lead to a series of events that could place the operator and patient at risk of injury. Siemens Medical Solutions USA, Inc
Biologics Platelets Pheresis Leukocytes Reduced W1165132064340 Class II Blood product, with a low platelet concentration, was distributed. Central Shared Services, LLC.
Devices Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacement device. For spinal surgery. The Synthes XRL device is intended to be used with the Synthes supplemental internal fixation systems (e.g., USS, including MATRIX, Pangea, and TSLP). Product no. 03.807.507, lot no. 8029684, and product no. 03.807.508, lot no. 8029689. Class II Two lots of the Synthes XRL Medium Trial-Central Body device were incorrectly etched with the incorrect dimensions for height. Synthes, Inc.
Drugs LOSARTAN POTASSIUM Tablets, USP, 50 mg, 30 count bottles, Rx only, Manufactured by Arrow Pharm (Malta) Ltd., Bizebbugia, Malta, Packaged by GSMS, Inc. Camarillo, CA --- NDC 60429-317-30 Lot Number GS003057. Exp Date 03/2016. Class II Presence of Foreign Substance; some bottles may contain debris that was swept up during cleaning Golden State Medical Supply Inc.
Devices SBi RingFix Olive Wires Product Usage: These are temporary devices indicated for: osteosynthesis of fractures with small osteoarticular fragments, fixation of open and closed fractures, arthrodesis, sepsis, limb lengthening, and osteotomy. item #451-3004, lot V3R0R. Class II Small Bone Innovations (SBI) is recalling non-sterile RingFIX Olive Wires labeled as item #451-3004 Drill tip 1.8 mm diameter 400mm olive k-wire packaged with item #451-3005 Bayonet tip 1.8mm diameter 400mm olive k-wire inside. Small Bone Innovations, Inc.
Cosmetics True Liquid Hand Soap, 15 oz container. Redwood Fragrance All lot codes are included Class II Lafco Enterprises, Inc. dba LAFCO NY is recalling all lots and all varieties of its True Liquid hand soap due to a potential bacterial contamination. Lafco Enterprises Inc
Cosmetics True Liquid Hand Soap, 15 oz container. Marine Fragrance All lot codes are included Class II Lafco Enterprises, Inc. dba LAFCO NY is recalling all lots and all varieties of its True Liquid hand soap due to a potential bacterial contamination. Lafco Enterprises Inc
Cosmetics True Liquid Hand Soap, 15 oz container. Chamomile Lavender Fragrance All lot codes are included Class II Lafco Enterprises, Inc. dba LAFCO NY is recalling all lots and all varieties of its True Liquid hand soap due to a potential bacterial contamination. Lafco Enterprises Inc
Cosmetics True Liquid Hand Soap, 15 oz container. Gardenia Fragrance All lot codes are included Class II Lafco Enterprises, Inc. dba LAFCO NY is recalling all lots and all varieties of its True Liquid hand soap due to a potential bacterial contamination. Lafco Enterprises Inc
Cosmetics True Liquid Hand Soap, 15 oz container. Champagne Fragrance All lot codes are included Class II Lafco Enterprises, Inc. dba LAFCO NY is recalling all lots and all varieties of its True Liquid hand soap due to a potential bacterial contamination. Lafco Enterprises Inc
Cosmetics True Liquid Hand Soap, 15 oz container. Feu de Bois Fragrance All lot codes are included Class II Lafco Enterprises, Inc. dba LAFCO NY is recalling all lots and all varieties of its True Liquid hand soap due to a potential bacterial contamination. Lafco Enterprises Inc
Cosmetics True Liquid Hand Soap, 15 oz container. Fleurs de Baies Fragrance All lot codes are included Class II Lafco Enterprises, Inc. dba LAFCO NY is recalling all lots and all varieties of its True Liquid hand soap due to a potential bacterial contamination. Lafco Enterprises Inc
Cosmetics True Liquid Hand Soap, 15 oz container. Apricot Fragrance All lot codes are included Class II Lafco Enterprises, Inc. dba LAFCO NY is recalling all lots and all varieties of its True Liquid hand soap due to a potential bacterial contamination. Lafco Enterprises Inc
Drugs Marcaine (bupivacaine HCl) injection, USP, 0.25%, Preservative-Free, 10 mL (25 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USP, NDC 0409-1559-10. Lot #: 34-440-DD, Exp 10/15 Class I Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution. Hospira Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W051513148204 Class II Blood product, labeled as leukoreduced were not tested to verify the White Blood Cell count, was distributed Innovative Blood Resources
Biologics Platelets Pheresis Leukocytes Reduced W091010301993; W091010301993 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Oklahoma Blood Institute - Sylvan N Goldman Center
Biologics Red Blood Cells Leukocytes Reduced W091010144602; W091009168622 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Oklahoma Blood Institute - Sylvan N Goldman Center
Biologics Red Blood Cells Leukocytes Reduced Irradiated 4662137 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Oklahoma Blood Institute - Sylvan N Goldman Center
Biologics Source Plasma AB1397412 Class III Blood products, collected from a donor with no arm inspection, were distributed. Bio-Save Resources Of Albuquerque LLC
Devices Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL-L-GSTpi-438), a liquid tissue culture supernatant. For in vitro diagnostic use. Product Code: NCL-L-GSTpi-438; Lot Numbers and Expiration Dates: 6018777, Expires 2014-05; 6023260, Expires 2014-12; 6026297, Expires 2015-05; 6026980, Expires 2015-06 Class II Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (Product Code: NCL-L-GSTpi-438) does not function as intended up to the expiry date on the product labeling. This was detected through an ongoing stability program. There is a linkage between the age of the product and staining intensity. Leica Microsystems, Inc.
Devices Arrow® Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or arterial access and device introduction to the central circulation. Product codes and lot numbers: AK-09903-A 23F13G0162 AK-09903-S RF3064511 CDC-09903-1A 23F13G0642 AK-09903-J 23F13G0400 ASK-09903-CMC RF3064673 NL-09903-S 23F13G0630 AK-09903-LFSP RF3065449 ASK-09903-CMC 23F13G0343 NR-09903-S 23F13G0180 AK-09903-S 23F13G0204 ASK-09903-NKC 23F13G0336 SI-09903-E RF3064710 AK-09903-S RF3064956 ASK-09903-TJ 23F13G0567 SI-09903-E RF3064915 AK-09903-S 23F13H0195 CDC-09903-1A RF3065316 Class II Arrow is recalling the Arrow® Percutaneous Sheath Introducer Kits due to dilator tip damage noted during internal inspection. Dilator tip damage has the potential to result in vessel damage. Arrow International Inc
Devices Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure the soft tissue thickness is equal to or less than 6 mm. For use with Baha Attract hearing system. Outer Package Lot COH523440, COH485876, and COH484221 with/Device Lot No. 131008 Class II Cochlear America is recalling Cochlear Baha Soft Tissue Gauge due to possible manufacturing imperfection in the smooth surface of the metal that could potentially leave residual metal on the patient's skin. Cochlear Americas Inc.
Devices Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure the soft tissue thickness is equal to or less than 6 mm. For use with Baha Attract hearing system. Product Code: NCL-L-CD15; Lot Numbers and Expiration Dates: 6017936, Expires 2014-08; 6015073, Expires 2014-03 Class II Product does not function as intended up to the expiry date on the product labeling. There is a link between the age of the product and staining intensity. Leica Microsystems, Inc.
Devices Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum. Catalog No: FV431T, FV434T, FV433T, FV459T, FV078P, FV494T, FV676T, FV324T Lot No: 4505150452,4505156642,4505164365,4505134636,4505150384,4505156634,4505246780,4505394315,4505150371,4505174213,4505187583,4505366616,4505134635,4505187582,4505134629,4505212089,4505199667,4505150340,4505171900,4505168804 Class II AIC (USA) received information regarding 3 complaints in which the deflector did not move freely on the ventricular catheter. Aesculap, Inc.
Devices AXIOM Luminos dRFsystem The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. Model number: 10094200, serial numbers:4332 4291 4323 4430 3061 4331 4238 4297 4201 4024 3098 4252 4372 4354 4077 3050 3108 4327 4342 4251 3053 3114 4156 3145 3096 4043 3181 4208 3090 4143 4051 4199 4401 4405 4151 4373 4276 Class II It was determined that under rare environmental conditions (i.e., extremely dry air in combination with a highly isolated floor) electrostatic discharges (ESD) >8 kV may trigger an unintended movement of the AXIOM Luminos dRFsystem which may lead to an emergency situation and pose danger to the patients, operating personnel or to the unit. Siemens Medical Solutions USA, Inc
Food Greens+ Vegan Crisp Bars - Dark Chocolate Almond Blueberry in 1.4 oz packages. Lot Codes: BB 10MAY14 F1 2883; BB 11JUN14 F2 3153; BB09JUL14 F1 3433; BB3AUG14 F1, F2 0034; BB23AUG14 F1-F2 0234; BB03OCT14 F3 0624 Class II Undeclared milk protein in chocolate coating. Orange Peel Enterprises, Inc.
Food Greens+ Vegan Crisp Bars - Dark Chocolate Peanut Butter in 1.4 oz packages. Lot Codes: BB 11MAY14 F2 2833; BB 11JUN14 F2 3152; BB 09JUL14 F1 3433; BB 03AUG14 F1, F1 0034; BB 23AUG14 F1-F2 0234; BB 03OCT14 F1-F2 0624 Class II Undeclared milk protein in chocolate coating. Orange Peel Enterprises, Inc.
Food Greens+ Vegan Crisp Bars - Dark Chocolate Almond Coffee Crisp in 1.4 oz packages. Lot Codes: BB 10MAY14 F1 2833; BB 11JUN14 F1 3153; BB 09JUL14 F1 3433; BB 03AUG14 F1, F2 0034; BB 03OCT14 F1-F2 0624 Class II Undeclared milk protein in chocolate coating. Orange Peel Enterprises, Inc.
Devices Composix" LP with Echo PS" 10x13 HUXH0294 HUXL0314 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. HUXH0294, HUXL0314 Class II Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Davol, Inc., Subs. C. R. Bard, Inc.
Devices Composix" LP with Echo PS" 6x10 Reorder Number: 0144610 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Lot Number: HUXK1536 Class II Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Davol, Inc., Subs. C. R. Bard, Inc.
Devices Composix" LP with Echo PS" 6x8 Reorder Number: 0144680 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Lot Number: HUXK0073, HUXK1537 Class II Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Davol, Inc., Subs. C. R. Bard, Inc.
Devices Bard® Composix" LIP Mesh with Echo PS" 7"x9" Reorder Number: 0144790 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Lot Number: HUXK1539 Class II Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Davol, Inc., Subs. C. R. Bard, Inc.
Devices Bard® Composix" LIP Mesh with Echo PS" 8"x10" Reorder Number: 0144810 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Lot Number: HUXK1540 Class II Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Davol, Inc., Subs. C. R. Bard, Inc.
Devices Bard®Ventralight" ST Mesh with Echo PS" 10"x13" Reorder Number: 5955113 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Lot Number: HUXK0900, HUXK0901, HUXL1148 Class II Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Davol, Inc., Subs. C. R. Bard, Inc.
Devices Bard® Ventralight" ST Mesh with Echo PS" 12"x14" Reorder Number: 5955124 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Lot Number: HUYA1057 Class II Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Davol, Inc., Subs. C. R. Bard, Inc.
Devices Bard® Ventralight" ST Mesh with Echo PS" 4.5" Circle Reorder Number: 5955450 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Lot Number: HUXH0535, HUXH0696, HUXK0747 Class II Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Davol, Inc., Subs. C. R. Bard, Inc.
Devices Bard® Ventralight" ST Mesh with Echo PS" 4"x6" Reorder Number: 5955460 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Lot Number: HUXH0695 Class II Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Davol, Inc., Subs. C. R. Bard, Inc.
Devices Bard® Ventralight" ST Mesh with Echo PS" 6" CircleReorder Number: 5955600 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Lot Number: HUXH0694, HUXL1149, HUXL1150, HUYA1005 Class II Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Davol, Inc., Subs. C. R. Bard, Inc.
Devices Bard® Ventralight" ST Mesh with Echo PS" 6"x10" Reorder Number: 5955610 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Lot Number: HUXK0744, HUXL1004 Class II Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Davol, Inc., Subs. C. R. Bard, Inc.
Devices Bard® Ventralight" ST Mesh with Echo PS" 6"x8" Reorder Number: 5955680 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Lot Number: HUXH0688, HUXK0743, HUXL0803, HUXL0804 Class II Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Davol, Inc., Subs. C. R. Bard, Inc.
Devices Bard® Ventralight" ST Mesh with Echo PS TM 7"x9" Reorder Number: 5955790 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Lot Number: HUXK0899 Class II Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Davol, Inc., Subs. C. R. Bard, Inc.
Devices Bard® Ventralight" ST Mesh with Echo PS" 8" Circle Number: 5955800 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Lot Number: HUXK0058 Class II Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Davol, Inc., Subs. C. R. Bard, Inc.
Devices Bard® Ventralight" ST Mesh with Echo PS" 8"x10" Reorder Number: 5955810 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Lot Number: HUXH0691, HUXL0336, HUXL0495, HUXL0660, HUXL1006, HUXL1007, HUXL 1147 Class II Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Davol, Inc., Subs. C. R. Bard, Inc.
Devices BG3515-5 US 5mL BioGlue Surgical Adhesive. BioGlue Surgical Adhesive (BioGlue) is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of of large vessels (such as aorta, femoral, and carotid arteries). 12MUV034, 12MUX035, 12MUV069, 12MUV037, 12MUV038, 12MUV040, 12MUV041, 12MUV042, 12MUV043, 12MUV044, 12MUV045, 12MUV046, 12MUV047, 12MUV048, 12MUV049, 12MUV050, 12MUV051, 12MUV052, 12MUV053, 12MUV054, 12MUV055, 12MUV056, 12MUV057, 12MUV058, 12MUV059, 12MUV060, 12MUV061, 12MUV062, 12MUV063, 12MUV064, 12MUV065, 12MUV067, 12MUV068, 12MUV069, 12MUV070, 12MUV071, 12MUV072, 12MUV073, 12MUV074, 12MUV075, 12MUV076, 13MUV001, 13MUV002, 13MUV003, 13MUV004, Class II Serum albumin component monomer failed to meet internally established end of shelf-life specification. CryoLife, Inc.
Devices Monoswift® PGCL [poly (glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0 PGCL; part number L936. Product is labeled sterile. The product is sealed inside an inner foil pouch with an outside Tyvek® pouch. It is an undyed, monofilament synthetic absorbable suture with needle, size 3/0 (2.0 metric), PS-1 Needle Lot 130826-08, expiration 2015-07. Class II CP Medical, Inc., is recalling one lot of Monoswift PGCL [poly (glycolide-co-caprolactone)] Absorbable Sutures for failing to meet the USP minimum average value for knot pull (tensile) strength. C P Medical Inc.
Devices Integra Licox Test Kit REF BC10R Rx Only An accessory provided for use with the LCXO2 and AC31 PtO2 Monitors. It provides users with a secondary means to verify the monitor's PtO2 state-of-calibration (but does not provide calibration) when needed by providing a specific electrical signal to the monitor. Catalog Number BC10R Lot Nos: 051113, 100913, 140513, 161013, 25013 Class II Integra LifeSciences has identified through a small number of complaints that some lot numbers of Licox Test Kits (Catalog Number BC10R) may provide erroneous "calibration test failure" message when they are used with the Licox PtO2 Monitor (LCSO2, or may provide an erroneous out of range result with the Licox CMP Brain Tissue Oxygen and Temperature Monitor (AC31). Integra LifeSciences Corp.
Food CAPTAIN KRATOM GOLD XL 30 Grams MAENG DA CAPSULES CAPTAIN KRATOM GOLD 15 GRAMS MAENG DA CAPSULES CAPTAIN KRATOM PREMIUM THAI POWDER 15 Grams CAPTAIN KRATOM PREMIUM BALI CAPSULES 15 Grams CAPTAIN VIETNAM KRATOM PREMIUM PLATINUM STRAIN 15 GRAMS CAPTAIN KRATOM PREMIUM THAI LEAF 15 Grams CAPTAIN KRATOM 30 grams Thai Capsules XL CAPTAIN KRATOM PREMIUM THAI CAPSULES 8 Grams MINI CAPTAIN KRATOM PREMIUM THAI RESIN 6 Grams CAPTAIN VIETNAM KRATOM PREMIUM PLATINUM STRAIN 30 GRAMS UPC 42008 06908 Class II Prep Enterprises is recalling Captain Kratom, Arena Ethnobotanicals and Kratom Pro products because they may be contain Kratom (mitragyna speciosa). Prep Enterprises Llc
Food Arena Ethnobotanicals and Kratom Pro, sizes: 1oz, 4oz, and 8oz. n/a Class II Prep Enterprises is recalling Captain Kratom, Arena Ethnobotanicals and Kratom Pro products because they may be contain Kratom (mitragyna speciosa). Prep Enterprises Llc
Drugs CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 9% Povidone-iodine (USP) Surgical Hand Scrub; CareFusion, Vernon Hills, IL 60061 USA, NDC 57613-003-18 4451B; 4451GL Class II Subpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner. The available iodine in the product is less than as stated on the product label. Carefusion 2200 Inc
Drugs CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 15% Povidone-iodine (USP) Surgical Hand Scrub; CareFusion, Vernon Hills, IL 60061 USA, NDC 57613-013-15. 4452B Class II Subpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner. The available iodine in the product is less than as stated on the product label. Carefusion 2200 Inc
Food Hawaiian Coconut Pudding, Haupia Luau Dessert; Packaged in Net Wt. 2 oz. (57 g); Net wt. 4 oz. (114 g) and Net wt. 48 oz. (3 lb) 1.36 kg. Ingredients: Sugar, coconut "powder, corn starch, locust bean gum, carrageenan, maltodextrin. 2 oz UPC 073562000504; 4 oz UPC 073562000559; 3 lb UPC 073562000511, NOH Foods of Hawaii, Honolulu, HI All codes 2 oz UPC 073562000504; 4 oz UPC 073562000559; 3 lb UPC 073562000511, Class I Consumer complaint initiated testing of the product by University of Nebraska who found >5000 ppm of milk allergen. E & M Corporation, Dba Noh Foods International Of Hawaii
Devices IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number 881030; ISP LX SPECT, Model number 881035), Philips Medical Systems. A medical software system for diagnostic imaging data viewing. ISP DX/HX/EX; Model number 881001, Serial numbers 35033, 85298, 80861, 81017, 81021, 81191, 82085, 82124, 82144, 82148, 82242, 85029, 85030, 85033, 85164, 85166, 85183, 85247, 85302, 85324, 85337, 85353, 85357, 85359, 85397, 85401, 85402, 87004, 87014, 87158, 87176, 87177, 87182, 87200, 92003, 95043, 95044, 95045, 95046, 95047, 95048, 95049, 95050,  ...
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Class II During SPECT reconstructions using Attenuation Correction and Scatter Correction, no Scatter Correction is being applied in the AutoSPECT Pro application on IntelliSpace Portal. In addition, resolution recovery is not applied correctly in SPECT reconstructions using Astonish in AutoSPECT Pro on Intellispace Portal. Philips Medical Systems (Cleveland) Inc
Devices MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator. Beginning Lot Code 1204275; Ending Lot Code 1401075 (Lot code indicates the date of manufacture = yymmdds, where s is the shift). Class II ConMed Corporation has received complaints regarding sparking, no output and burning at the cord set connection. The complaints have been confirmed by ConMed. ConMed Corporation
Devices Kenex Radiation Shield and surgical lamps installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems. Kenex Suspension installed with Radiation shield and lamp with following model numbers: E03971AA;E03981AA;E30421AA;E30431AA;E30591CA;E30591HD;E30591HL;E30591EB;E30511P;E30591AB;E30591B;E30511Q;E30591C;E30591A;E30591RR;E30591CB;E30591E;E33591PA;E33591PC. Product Usage: Personnel protective shield is a device intended for medical purposes to protect the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation. Mfg Lot or Serial # System ID 00000226588WK2 309655FC1 00000215577WK8 312878WCL 00000224993WK6 318473RCATH2X 00000244933WK8 401274MV2 00000286625WK9 503230CV3 00000199483WK9 619457SCL 00000273112WK3 804862SR7A 00000234084WK2 915563LUADV 00000063736YY3 MCTHKGMN 00000416503WK1 1222 00000299868WK0 215662C3 00000312304WK9 215770C1 00000367696WK2 215861LC 00000312714WK9 301891LC 00000321508WK4 313421LC 00000309562WK7 317818MDI120 00000438039WK0 317818MDI905 00000503165WK3 318462BCL 00000505246WK9 318473RCATH4 00000281715WK3 318494LC1 00000405780WK8 318494LC2 00000405779WK0  ...
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Class II GE Healthcare has recently become aware of a potential safety issue due to the improper installation of a Kenex ceiling suspended radiation shield and surgical lamp. This issue is not related to the design of the Kenex product. The affected products are limited to installations completed or contracted by GE Healthcare. There has been a reported incident of a radiation shield falling from the ceiling causing a minor injury. GE Healthcare, LLC
Food American Spoon® Sour Cherry PRESERVES Richer in Fruit (56 Brix) Made in Small Batches Net Wt. 9.5 oz/269g, glass jar INGREDIENTS: Red Tart Cherries, , Sugar, Lemon Juice, Pectin. ALLERGY INFORMATION: Manufactured in a facility that also processes soybeans, milk, eggs, fish, and tree nuts. Refrigerate after opening American Spoon Foods PETOSKEY, MICHIGAN 49770 800 222 5886 UPC 0 19363 01010 6 code 3322 The code is a 12 digit code printed on the side of the jar as: 3322000*** and with a Best Flavor by date of 11/2016. The missing digits include the sequential batch number for the day and a sequential jar number for each jar in the batch. Class II American Spoon, Sour Cherry Preserves, 9.5 oz (UPC 019363010106) may contain mold. American Spoon Foods, Inc.
Food REDVINES FRUIT VINES Bites Cherry ARTIFICIALLY FLAVORED NET WT, 2 oz (57G) Nutrition Facts: ***Sodium 35g***ALLERGEN INFORMATION: CONTAINS WHEAT***AMERICAN LICORICE COMPANY, UNION CITY, CA 94587 UPC 0 41364 82001 9 BEST BEFORE 11/23/14 2 Class III The nutritional panel on the packaging incorrectly states the sodium content as 35g, when it should read 35mg. American Licorice Company
Food REDVINES FRUIT VINES Bites Strawberry ARTIFICIALLY FLAVORED NET WT, 2 oz (57G) Nutrition Facts: ***Sodium 35g***ALLERGEN INFORMATION: CONTAINS WHEAT***AMERICAN LICORICE COMPANY, UNION CITY, CA 94587 UPC 0 41364 82006 4 BEST BEFORE 11 24 14 3 Class III The nutritional panel on the packaging incorrectly states the sodium content as 35g, when it should read 35mg. American Licorice Company
Food Lily Bloom's Kitchen Chocolate Coconut Poparoons Poparoons do not contain a lot number or code Class I Lily Bloom's Kitchen Poparoon flavors that contain milk which was not listed on the label include lemon, key lime, strawberry, blueberry and chocolate dipped in a white chocolate coating. Lily Bloom's Kitchen
Food Raclette du Haut Livradois Ste Fromagere du Livradois 63980 Fournols 13lbs or cut and wrapped (weight may vary) wrap in a wax paper in a case or wrapped in plastic wrap if cut; refrigerated lot #350 Class I Ste Fromagere du Livradois of Fournols, France is recalling Haut Livradois brand Raclette and Montboissie cheeses lot#350 because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. STE FROMAGERE DU LIVRADOIS
Food Montboissie du haut- Livradois Manufactured by Ste Fromagere du Livradois 63980 Fournols 13lbs or cut and wrapped (weight may vary) wrapped in a wax paper in a case or wrapped in plastic wrap if cut; refrigerated lot #350 Class I Ste Fromagere du Livradois of Fournols, France is recalling Haut Livradois brand Raclette and Montboissie cheeses lot#350 because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. STE FROMAGERE DU LIVRADOIS
Devices Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT series, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex, and the MX8000 Dual v. EXP scanners) Brilliance CT 6: M/N: 728256; S/N: 3001, 3002, 3005, 3007, 3014, 3016, 3019-3021, 3025, 3026, 3028, 3032-3036, 3045, 3046, 3049, 3051, 3052, 3057, 3058, 3060, 3062, 3064-3066, 3068, 3071, 3073, 3074, 3076-3081, 3083, 3084, 3090, 3093-3095, 3097, 3101, 3102, 3104, 3106-3108, 3112-3115, 3118-3121, 3124, 3126, 3128, 3129, 3131, 3132, 3134,  ...
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Class II A customer reported that the table top had become free floating. A Field Service Engineer (FSE) confirmed that the service latch had become disengaged. Philips Medical Systems (Cleveland) Inc
Devices The Stryker NAV3i Platform is a mobile cart platform consisting of the sub-components Stryker Nav3 Graphite Camera, SPC-3 Computer and IO-Tablet (touch screen) as well as the monitor, articulated arms and cart housing. This Navigation system is used in combination with surgical software for cranial, spine, ENT, orthopedic and trauma procedures. Stryker Product Number: 7700-800-000 Stryker Serial Numbers: 15097, 15098, 15099, 15102, 15103, 15104, 15105, 15106, 15107, 15109, 15110, 15111, 15112, 15113, 15114, 15115, 15116, 15117, 15118 Class II The Stryker NAV3i Platform Power Boxes produced between December 9, 2013 and March 7, 2014 may have been assembled without electrical insulation of the soldering joints Stryker Instruments Div. of Stryker Corporation
Devices The NAV3i Platform Power Box supplies the electrical components with power (e.g. Stryker Nav3 Graphite Camera, SPC-3 Computer, IO-Tablet (touch screen) and the monitor). Stryker Product Number: 7700-853-000 Stryker Serial Numbers: 10004 Class II The Stryker NAV3i Platform Power Boxes produced between December 9, 2013 and March 7, 2014 may have been assembled without electrical insulation of the soldering joints Stryker Instruments Div. of Stryker Corporation
Devices enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM) (IM) v8.06 --- For in vitro quantitative measurement of a variety of analytes of clinical interest --- Background: The enGen (TM) Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TCAutomation) for pre-analytical and post-analytical sample and data management. In addition to an Automated Track Sub-system, the enGen (TM) System includes one or more VITROS Chemistry, Immunodiagnostic and/or Integrated Systems (clinical analyzers) as well as a Data Management Subsystem (Middleware), and a Software Configuration (gsb) File. The enGen System is typically interfaced with a Laboratory Information System (LIS) via connectivity facilitated at the Data Management Subsystem level. enGen (TM) Laboratory Automation Systems Configured with enGen (TM) Select or Custom (TM) v3.2.2 and below with Data Innovations, LLC Instrument Manager (TM) v8.06 with Data Innovations, LLC TCA Driver v8.04.0020 and below Class II Software Anomaly: Ortho Clinical Diagnostics (OCD) has become aware that if a sample requires follow-up action, such as dilution or retesting due to a mechanical issue, it is possible for that sample to be routed to the sample storage drawer (Storage) prior to the completion of the necessary pending action. A delay in patient test result(s) reporting could occur as operator is not alerted that results have not been produced and that further actions are required. Ortho-Clinical Diagnostics
Devices CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient alignment. CARINAiso = Part # 0007536-0001 CARINAsim = Part #0007535-0002 Class II Potential for patient to be marked incorrectly. Customers currently using CARINAsim or CARINAiso systems can encounter two safety relevant errors in the operating instructions (CARINAsim MAN-1236 Rev 2 / CARINAiso MAN-1237 Rev 2) LAP of America Laser Applications, LLC
Devices Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) and 3.5mm x 30mm (catalog number 285330S). Screws are provided in different diameters and lengths and are used to anchor various sizes and shapes of bone fixation plates when treating bone fractures or reconstruction of the ankle, foot or hand. SURFIX 3.5 mm D X 22 mm L /Cat No 285322S Lot no. F6S6; SURFIX 3.5 mm D X 30 mm L /Cat. No. 285330S Lot no. F6ZL Class II New Deal has identified through a complaint report that some 3.5 mm Diameter x 22 mm Length Surfix screws in Lot no. F626 (Catalogue No. 285322S) have been packaged and labeled as 3.5mm Diameter x 30 mm Length Surfix screws (Catalogue No. 285330S). Integra LifeSciences Corporation
Food Dragonfly Brand Crushed Chili Powder, Net Wt. 6.3 oz plastic tubs. Product of Thailand UPC 7 21557-53317 8 Packed for: U.S. Trading Co., 21118 Cabot Blvd., Hayward, CA 94545 Lot 359XP Class I IEH sample of Crushed Chili Powder collected at retail was positive for Salmonella Ba reilly. Us Tov, Inc. Dba U.s. Trading Company
Devices Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff. catalog number 3008895 : material numbers 3008236, 3009966, 3009917 with serial numbers: 1048 200619 200585 200656 300010 100066 14498 100087 200305 200663 200248 200606 300047 1040 100182 100187 200442 200037 200716 200111 300051 1041 100428 100128 200479 200586 200648 200009 300045 100107 100037 100213 200665 200034 200722 200134 300027 100272  ...
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Class II There is a potential safety risk associated with potentially damaged locking pins within the bracket of non-wireless versions of Continuum systems shipped prior to March 2008. Bayer Corp
Devices Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtronic Model 8780 Ascenda Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and a Model 8780 Ascenda Intrathecal Catheter. N457062003 Class II Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits. Medtronic Neuromodulation
Devices Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer. Serial Numbers: 2840314W8065, 2840314W8062W, 2840314W8066W, 2840314W8067 2840314W8073, 2840314W8064, 2840314W8056W, 28401082720 28407083579, 28401137611W, 28403083045W Class II Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which could result in patient injury Hologic, Inc.
Devices Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast. Serial Numbers: 1800314 7263, 180031472, 18002023051PR Class II Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which could result in patient injury Hologic, Inc.
Food Gavina Northwest Blend Dark Whole Bean Bag Net Wt. 5lb, Product label reads in part "***085895***DECAF EUROPEAN BLEND 5LBS WHOLEBEAN BAG***" Lot No. 85895 Class III F. Gavina and Sons Inc. is recalling Gavina Northwest Blend Dark whole beans because it was mislabeled as decaffeinated product. F. Gavina & Sons Inc.
Food Rockman (Brand) Raw Peanuts with Red Skin, 12 oz. Packaged in plastic pouch. 12oz/60bags/carton. Labeled as "PEANUT" on packaging. Product labeling reads in part: "ROCKMAN***PEANUT N.W.: 12 OZ (342G)***DISTRIBUTED BY: ROCKMAN (AUSTRALIA) PTY LTD.***AUSTRALIA***PRODUCT OF CHINA***DISTRIBUTED BY: ROCKMAN COMPANY (USA) INC.***COMMERCE, CA***PRODUCT OF CHINA***". No codes. Class II Rockman Company USA, Inc. inititated the recall of raw peanuts due to mold and mis-labeling: missing Allergen Statement, missing Nutrition Facts Information, missing List of Ingredients, and inaccurate Distributor address and phone number. Rockman Company Usa Inc
Food Rockman (Brand) Skinless Peanut, 12 oz. Description: blanched skinless peanut. Packaged in plastic pouch. 12oz/60bags/carton. Product labeling reads in part: "ROCKMAN***SKINLESS PEANUT 12 0Z (342G)***DISTRIBUTED BY: ROCKMAN (AUSTRALIA) PTY LTD.***AUSTRALIA***PRODUCT OF CHINA***DISTRIBUTED BY: ROCKMAN COMPANY (U.S.A.) INC.***COMMERCE, CA***PRODUCT OF CHINA***". No codes. Class II Rockman Company USA, Inc. inititated the recall of raw peanuts due to mold and mis-labeling and blanched peanuts due to mis-labeling. Rockman Company Usa Inc
Devices Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical Wound Drain***" Two different sizes, 10 units per box: 19 Fr Round Hubless part number 7110; 24 Fr Round Hubless part number 7118. AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. 19 Fr Round Hubless part number 7110 lot number 016913; 24 Fr Round Hubless part number 7118 lot numbers 028013, 028113 and 028213.. Class II The recalling firm reported there was inadvertent omission of quarterly (Q4 - 2013 and Q1 - 2014) dose audits/verifications on the affected products. All of the affected products were appropriately sterilized Bacterin International, Inc.
Biologics Sterile Cord Blood Collection Unit, Anticoagulant Citrate Phosphate Dextrose Solution (CPD), Code 791-08 (PALL Medical label) and 791-09V (ViaCord label), UPC code for Pall product code: 791-08: (Case box): (01) 30636207307966 There is no UPC code issued to the ViaCord product. --- The systems are packaged STERILE within a "sterilization pouch" (1 system/pouch) and placed within a foil envelope (1 pouch/ envelope). There are 24 units packaged per case box. Pall Sterile Cord Blood Collection System Code 791-08: Lot number 1356443 (Expiry Date 10/2016); ViaCord's Sterile Cord Blood Collection System, Code 791-09V: Lot numbers 1356441 and 1356442 (Expiry Date 10/2016) Class II Sterile Cord Blood Collection Systems, with a limited number of reports of a blood leaks, were distributed. Pall Corporation
Devices Siemens Ysio Systems Product Usage: The Ysio (New RAD-FAMILY) systems are radiographic systems used in hospitals, clinics, and medical practices. Ysio enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) ad emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio System is not meant for mammography. The Ysio uses an integrated or portable digital detector for generating diagnostic images by converting x-rays into electronic signals. Ysio is also designed to be used with conventional film/screen or Computed Radiography *CR) cassettes. Model nos. 10281013,10281163 with serial nos. 30080 23071 20045 31072 22523 22776 22787 31137 23021 20034 20112 22775 22279 22283 22280 22875 22290 22576 22848 31060 31136 31064 31138 22326 23068 22288 22114 22714 21100 22960 23082 22169 22601 21065 21205 31017 31135 31040 21086 22972 30038 30047 23029 22538 22658 21088 21103 31120 21224 21221 21223 21085 31122 22597 22388 22391 20115 22104 22583 23097 22943 22942 22585 22781 21089 20093 20110 21066 22404 22796 22506 21031 30040 22119 22599 22844 22148 22880 21139 21006 20155 30055 30024 21114 21112 21122 31069 21185 30051 31078 30076 31012 22429 22190 31010 31011 22146 22527 22520 22126 22128 23138 31018 22836 23083 23036 22163 20089 20107 20088 20106 21052 22727 23098 22135 22737 22872 22542 22549 22551 22567 22500 31075 22449 30032 22350 31128 22389 31004 22984 30028 23020 31026 31134 21213 22247 22347 30078 22428 22137 22917 22873 31115 20167 31053 31081 21174 22029 22725 22724 31094 22286 31019 22093 22933 22920 22895 22681 22676 22682 22019 22020 21098 31077 31119 30062 31054 22080 31121 30050 21057 22833 22840 22955 31093 22058 31046 22931 22847 22852 22309 21101 22612 21120 21117 21116 21118 22367 22600 22946 30021 22655 22705 23016 22699 22192 22251 22899 31028 21091 31071 22928 22275 21092 22254 21037 21077 21076 22839 22117 22609 22543 22821 30029 23118 22838 22842 21200 21209 21203 20149 21163 22708 21172 21171 21173 22248 31067 31066 23053 30066 30067 30063 22789 22857 22055 22050 22038 22051 22056 22037 22060 22242 22071 22208 22073 22632 22683 22666 22541 22537 22364 23127 23129 20094 22132 22026 22027 22225 23024 23022 30052 23130 23132 22092 21115 22456 22441 22021 22730 22743 22851 21113 22175 31003 22584 20047 21194 22786 31117 31145 23018 23019 22166 22170 22944 22945 31079 23038 22869 31103 31104 31095 31047 20113 30023 30027 30019 23113 22431 22778 22777 23047 21212 21211 23035 22216 23066 30037 22861 22859 22824 22755 22757 22693 22647 21188 21186 22656 21094 22390 21040 21039 22076 22630 31082 21108 22919 22825 22054 22059 22834 31143 22764 23096 22517 22177 22685 30033 30034 20105 22998 23057 22345 22849 22427 22606 22525 22435 22729 22370 22365 22366 22246 22509 22344 22700 30073 22966 22748 20185 21061 31037 23063 23054 21095 22081 22062 23117 22352 22353 22354 21148 31114 31133 22736 22618 22828 22958 22178 22458 22457 22695 21189 21187 21167 22702 22644 21175 21140 21023 23141 22462 21001 22759 21004 21005 22136 22211 21127 23059 23079 22120 23078 22202 22184 22804 22392 22214 22235 22234 22289 31096 31142 22948 31014 22316 22651 22795 31043 31045 21123 21013 22997 22293 23123 23126 22064 22592 22271 22914 21160 22338 Class II Excessive usage of cleaning liquid on Siemens Ysio Systems may cause infiltration of the generator console, which may lead to a short circuit causing an unintended release of radiation. Siemens Medical Solutions USA, Inc
Devices PATH THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Orthopaedic surgical instrument. Lot Number(s): 1153896, 1279714, 1288604, and 1314793 Class II Difficulty removing the cup adaptor from the impaction handle during surgery Microport Orthopedics INC.
Devices 115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature and /or maintain a desired patient temperature through conductive heat transfer. Part number 86165. Model Number 222S; Serial #s: 133-2-00697, 133-2-00698; 133-2-00699; 133-2-00700; 133-2-00701; 133-2-00702; and 133-2-00703:.Part # 86165 Class II The incorrect voltage component was placed into the device during manufacturing. This may make the device unable to maintain patient temperature during cooling mode. The device will continue to indicate that the unit is cooling because the compressor will continue to run, however water in the reservoir will begin to return to ambient temperature. The actual water temperature will be displayed but no alarms will alert the user of the loss of therapy condition. Cincinnati Sub-Zero Products Inc
Devices Spacelabs Medical Ultraview SL" Command Module, Model 91496. Detector and alarm, arrhythmia. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (SpO2) and cardiac output. Acquired data may then be communicated to an information network for display, recording, editing and analysis. Listing Number: D145750 Model: 91496. Class II A software anomaly causes temperature alarm limits to change to limits which are not physiologically possible and result in nuisance false positive alarms. Spacelabs Healthcare Inc
Devices Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da Vinci Surgical System IS 4000. The patient-side cart is positioned at the operating room table and contains four arms that are positioned over the target patient anatomy. The endoscope attaches onto any arm. The patient-side assistant attaches/detaches the endoscope and instrument intra-operatively. lot 380652-20 Class II Torque wrenches used to tighten certain PSC bolts were out of calibration. This could lead to over- or under-tightening of bolts that may result in system faults, mechanical sound (e.g. scraping, squeaking, rattling), cracks or vibration in the system. Intuitive Surgical, Inc.
Food KrustaVita® Bread of Life brand Sourdough Dark Rye Bread; Net Weight 20 oz (1.25 lb); packed in a clear plastic bag. UPC: 8 5243000200 6. Best By: MAY 28, 2014 Class II Royal Rye LLC is recalling their KrustaVita® Bread of Life rye bread due to undeclared soy. Royal Rye LLC
Devices Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting. Serial Numbers: ULD1412014, UUC13Z2011, A4A113Z2001. Class II Toshiba America Medical Systems, Inc. initiated a recall of Toshiba Infinix X-Ray (INFX-8000V/UU), because it has been found that although the Flat Panel Detector (FPD) touch sensor is activated during use, the error message is displayed and the audible signal continues sounding during the table movement of longitudinal tilt, and does not stop. Toshiba American Medical Systems Inc
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