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U.S. Department of Health and Human Services

Enforcement Report - Week of November 28, 2012

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Platelets Pheresis Leukocytes Reduced Washed 11LT03850- Part 1; 11LT03850- Part 2 Class II Blood products, which did not meet the acceptable product specifications for release, were distributed. American Red Cross Blood Services
Biologics Platelets 01KK17395 Class III Blood product, manufactured from Whole Blood unit with an extended collection time, was distributed American National Red Cross (The)
Devices Screw Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2069, JK2085, JK2102, JK2188, JK2171 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. NuVasive Inc
Devices 5.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2053 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. NuVasive Inc
Devices 5.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2051, JK2154 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. NuVasive Inc
Devices 5.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2042, JK2080, JK2151 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. NuVasive Inc
Devices 5.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2058, JK2054, JK2081, JK2143 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. NuVasive Inc
Devices 5.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2082, JK2095, JK2165 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. NuVasive Inc
Devices 5.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2059, JK2084, JK2148 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. NuVasive Inc
Devices 6.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2057, JK2157. Class II The tulip portion of the screw assembly can disengage from the shank after implantation. NuVasive Inc
Devices 6.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2083, JK2184 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. NuVasive Inc
Devices 6.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2052, JK2070, JK2098, JK2160, JK2093, JK2159 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. NuVasive Inc
Devices 6.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2071, JK2169, JK2167. Class II The tulip portion of the screw assembly can disengage from the shank after implantation. NuVasive Inc
Devices 6.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2039, JK2072, JK2168. Class II The tulip portion of the screw assembly can disengage from the shank after implantation. NuVasive Inc
Devices 6.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2060, JK2046, JK2180, JK2202, JK2213, JK2230, JK2231, JK2247, JK2244 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. NuVasive Inc
Devices 7.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2094, JK2096 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. NuVasive Inc
Devices 7.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2097, JK2190 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. NuVasive Inc
Devices 7.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2098, JK2187 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. NuVasive Inc
Devices 7.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2099, JK2186 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. NuVasive Inc
Devices 7.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2056, JK2100, JK2162 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. NuVasive Inc
Devices 7.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2101, JK2163 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. NuVasive Inc
Devices Screw Tulip , 5.5mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK1949, JK2068, JK2071, JK2078, JK2079, JK2170, JK2206, JK2375, JK2387, JK2398, JK2400 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. NuVasive Inc
Devices 4.5mm x 35mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2035, JK2131, JK2349 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. NuVasive Inc
Devices 4.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2036, JK2132, JK2350. Class II The tulip portion of the screw assembly can disengage from the shank after implantation. NuVasive Inc
Devices 5.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2037, JK2130, JK2037, JK2366 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. NuVasive Inc
Devices 5.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2043, JK2134, JK2364, JK2367 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. NuVasive Inc
Devices 5.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2044, JK2144, JK2378, JK2144 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. NuVasive Inc
Devices 6.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2055, JK2142, JK2172, JK2174, JK2192, JK2212, JK2173. Class II The tulip portion of the screw assembly can disengage from the shank after implantation. NuVasive Inc
Devices 6.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2045, JK2038, JK2140, JK2361, JK2362, JK2365, JK2368, JK2370, JK2369, JK2377, JK2379 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. NuVasive Inc
Devices 6.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: 2008400621, JK2039, JK2141, JK2191, JK2177, JK2178, JK2179, JK2181, JK2182, JK2183, JK2141, JK2181 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. NuVasive Inc
Devices 7.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2040, JK2147, JK2381, JK2141 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. NuVasive Inc
Devices 7.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2047, JK2152, JK2383, JK2394 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. NuVasive Inc
Devices 7.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2041, JK2146, JK2396, JK2397 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. NuVasive Inc
Biologics Source Plasma 706368653; 8910006160; 8910005703; 891004620; 891003971; 8910003354; 8910002601; 8910001907; 8910001428; 8910000658; 8910000058; 7060239477; 7060238870; 7060235693; 7060235343; 7060233737; 7060232841; 7060232527; 7060230676; 7060230508; 7060229117; 7060228623; 7060227644; 7060227269; 7060226330; 7060225860; 7060224951; 7060224579; 7060223952; 7060223407; 7060222382; 7060221936; 7060213791; 7060213434; 7060211929; 7060211221; 7060210664; 7060209842; 7060209180; 7060208408; 7060207256; 7060206774; 7060205914; 7060205391; 7060368156 Class II Blood products, collected from a donor whose suitability was not adequately determined, were distributed. CSL Plasma, Inc.
Biologics Red Blood Cells Leukocytes Reduced F42212, F42011, F42013,F42665, F44512, F44519, F42347, F41185, F42146, F42057, F42592, F42913, F42602, F41718, F43037, F42673, F42663, F43013, F42502, F42200, F42410, F42144, F43012, F42912, F42054, F43082, F42889, F43233, F43501, F43509, F43651, F43657, F41186, F41187, F43678, F41897, F41944, F42206, F42209, F42210, F42213, F42214, F42219, F42222, F42227, F42228, F42252, F42355, F35840, F41695, F41698,  ...
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Class III Blood products, which were not manufactured in accordance to acceptable product specifications, were distributed. Community Blood Center of Carolinas
Food "Titan Gelatinas***Postres de gelatina (Gelatin Dessert)***Sabor a China (Orange flavored)***Sabor a Fresa (Strawberry flavored)" none Class II Undeclared allergens (Yellow #5). Postres de Aqui, Inc.
Food "***Avena de Aquí Si Azucar Añadida****8oz****Fabricado por Postres de Aqui, Inc. Calle B Parrio Plamas Cataño PR 00962***" none Class III Lack of phenylketonurics warning. Postres de Aqui, Inc.
Drugs Orajel Kids My Way! Anticavity Fluoride (sodium fluoride) toothpaste, 0.24%, 3 oz (85 g) pump, Church & Dwight Col, Inc., Princeton, NJ 08543; UPC 3 10310 32370 7. Lot #: BI1041, Exp 02/13 Class II CGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substituted for PEG. Church & Dwight Inc
Food Kalamata Tapenade packaged in 7 oz clear plastic and 5 lb white plastic capacity containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026. Lot number KX21921; KT21921. Class I Sartori is recalling various dips, salsas, and cheese products which may have been manufactured onion mixes which were recalled by another firm due to possible contamination with Listeria monocytogenes. Sartori Inspirations, LLC
Food Mediterranean Tapenade packaged in 7 oz clear plastic and 5 lb capacity white plastic tubs, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026. Lot number MT21911; MT21921. Class I Sartori is recalling various dips, salsas, and cheese products which may have been manufactured onion mixes which were recalled by another firm due to possible contamination with Listeria monocytogenes. Sartori Inspirations, LLC
Food Tex Mex Smoked Gouda packaged in 7 oz clear plastic containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026. Lot number TM21931. Class I Sartori is recalling various dips, salsas, and cheese products which may have been manufactured onion mixes which were recalled by another firm due to possible contamination with Listeria monocytogenes. Sartori Inspirations, LLC
Food Smoked Gouda packaged in 7 oz clear plastic containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026. Lot number SG21931. Class I Sartori is recalling various dips, salsas, and cheese products which may have been manufactured onion mixes which were recalled by another firm due to possible contamination with Listeria monocytogenes. Sartori Inspirations, LLC
Food Pimento Cheese packaged in 7 oz clear plastic containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026. Lot number PM21931. Class I Sartori is recalling various dips, salsas, and cheese products which may have been manufactured onion mixes which were recalled by another firm due to possible contamination with Listeria monocytogenes. Sartori Inspirations, LLC
Food Jalapeno Pimento Cheese packaged in 7 oz clear plastic containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026. Lot number JC21931. Class I Sartori is recalling various dips, salsas, and cheese products which may have been manufactured onion mixes which were recalled by another firm due to possible contamination with Listeria monocytogenes. Sartori Inspirations, LLC
Food Mango Salsa packaged in 7 oz clear plastic containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026. Lot number MS21991. Class II Sartori is recalling various dips, salsas, and cheese products which may have been manufactured onion mixes which were recalled by another firm due to possible contamination with Listeria monocytogenes. Sartori Inspirations, LLC
Food Spinach Feta Dip packaged in 7 oz clear plastic containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026. Lot number FS21931. Class I Sartori is recalling various dips, salsas, and cheese products which may have been manufactured onion mixes which were recalled by another firm due to possible contamination with Listeria monocytogenes. Sartori Inspirations, LLC
Food Famous Thick Salsa packaged in 7 oz clear plastic containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026. Lot number FT21921. Class II Sartori is recalling various dips, salsas, and cheese products which may have been manufactured onion mixes which were recalled by another firm due to possible contamination with Listeria monocytogenes. Sartori Inspirations, LLC
Food Salsa Cream Cheese packaged in 7 oz clear plastic containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026. Lot number SC21931. Class II Sartori is recalling various dips, salsas, and cheese products which may have been manufactured onion mixes which were recalled by another firm due to possible contamination with Listeria monocytogenes. Sartori Inspirations, LLC
Devices RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary complications as a result of immobility, Thoracic or lumbar fracture, Cervical traction, Skeletal traction Model Number 208030, Serial Numbers: 00157087, 00157091, 00157288, 00157375, 00157405, RRCKOO011, RRHKOO065, RRHKOO074, RRHKOO096, RRHK00109, and RRHKOO117. Class II The firm is initiating a voluntary medical device correction for the RotoRest Delta Therapy System head pack. KCI has received complaints alleging patients experiencing skin breakdown on the head and face due to the positioning of the head pack. In a few instances, the patient received injuries ranging from Stage III to Stage IV pressure ulcers. KCI USA, Inc.
Devices Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical Hemostat. Sterile, single use device designed to prepare plasma from the patient's blood using a tabletop centrifuge. Part number 2113-0013, lot numbers T1203002, T1204005, and T1206001. Class II When preparing plasma using VitaPrep, it was reported that a small amount of blood collected in the bottom of the centrifuge cup following the centrifugation step. Firm has since discovered that if blood is present in the Luer connection of the VitaPrep following the blood draw step, this blood could be displaced to the outside of the syringe when the VitaPrep cap is reattached to the syringe. This small amount of blood (approximately 0.2 mL) would then migrate to the bottom of the centrifuge cup after the 2 minute centrifuge spin cycle. Stryker Orthobiologics, Inc.
Devices Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071) The THEO method is an in vitro diagnostic test for the quantitative measurement of Theophylline in human serum and plasma on the Dimension Vista(R) system. Lots 12135AE and 12171BB Class II Firm has received complaints from customers of "Abnormal Reaction" errors occurring on calibrations, QC and patient samples. The Abnormal Reaction flag is being triggered by an internal check in the method for atypical particle reagent aggregation. Siemens Healthcare Diagnostics, Inc.
Devices IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Customer Service: 888.499.0079. The Extremity Medical Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, ankle, hand and wrist. Product coding is listed as Catalog Number: Lot Number and are as follows: 118-30014:107509; 118-30016:107510; 118-30018:107511; 118-30020:107512; 118-30020:107513; 118-30022:107514; 118-30024:107515; 118-30026:107516; 118-40020:107457; 118-40025:107458; 118-40030;107529; 118-40030;107459; 118-40035:107460; 118-40040:107461; 118-40045:107462; 118-40050:107463; 118-40320:107613; 118-40325:107614; 118-40330:107615; 118-40330:107616; 118-40335:107617; 118-40340:107618; 118-40345:107619; 118-40350:107620. Class II Product Event Reports revealed that lag screw passes through washer (e.g. X-Post) intra-operatively. Extremity Medical LLC
Devices Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integrated Immunoassay Control. Intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance or reagent and instrument. . MAS Onmi IMMUNE: Catalog Number/lot number/ expiration date: OIM-101 - OIM14031 - 31  ...
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Class III In house testing confirmed that CK-MS and Insulin claimed in both Omni IMMUNE and Omni IMMUNE PRO products are displaying reduced stability. Microgenics Corporation
Veterinary DFA (Dairy Farmers of America), non-fat dry milk intended and labeled as animal feed 50 lb bags Lot Numbers: 1970, 1980, 2000, 2010 Class I The product may be contaminated with Salmonella. Dairy Farmers Of America, Inc.
Devices Product 100789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 VerSys Femoral Head Provisional 22mm +3.5 00789502220 VerSys Femoral Head Provisional 22mm -2 00789502230 VerSys Femoral Head Provisional 22mm +3 12/14 Neck Taper The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty. All lots distributed from lot 69998600 (2/20/1996) to present Class II Zimmer is in the process of enhancing the surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. These enhancements inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. The observed rate of occurrence for this type of event is approximately 0.001% or 1 in every 100,000 surgeries performed. Zimmer, Inc.
Devices 00789502601 VerSys Femoral Head Provisional 26mm -3.5 00789502602 VerSys Femoral Head Provisional 26mm +0 00789502603 VerSys Femoral Head Provisional 26mm +3.5 00789502604 VerSys Femoral Head Provisional 26mm +7 00789502605 VerSys Femoral Head Provisional 26mm +10.5 12/14 Neck Taper The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty. All lots distributed from lot 69998600 (2/20/1996) to present Class II Zimmer is in the process of enhancing the surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. These enhancements inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. The observed rate of occurrence for this type of event is approximately 0.001% or 1 in every 100,000 surgeries performed. Zimmer, Inc.
Devices . 00789502801 VerSys Femoral Head Provisional 28mm -3.5 00789502802 VerSys Femoral Head Provisional 28mm +0 00789502803 VerSys Femoral Head Provisional 28mm +3.5 00789502804 VerSys Femoral Head Provisional 28mm +7 00789502805 VerSys Femoral Head Provisional 28mm +10.5 12/14 Neck Taper The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty All lots distributed from lot 69998600 (2/20/1996) to present Class II Zimmer is in the process of enhancing the surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. These enhancements inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. The observed rate of occurrence for this type of event is approximately 0.001% or 1 in every 100,000 surgeries performed. Zimmer, Inc.
Devices 00789503201 VerSys Femoral Head Provisional 32mm -3.5 00789503202 VerSys Femoral Head Provisional 32mm +0 00789503203 VerSys Femoral Head Provisional 32mm +3.5 00789503204 VerSys Femoral Head Provisional 32mm +7 00789503205 VerSys Femoral Head Provisional 32mm +10.5 12/14 Neck Taper The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty. All lots distributed from lot 69998600 (2/20/1996) to present Class II Zimmer is in the process of enhancing the surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. These enhancements inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. The observed rate of occurrence for this type of event is approximately 0.001% or 1 in every 100,000 surgeries performed. Zimmer, Inc.
Devices . 00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602 VerSys Femoral Head Provisional 36mm +0 00789503603 VerSys Femoral Head Provisional 36mm +3.5 00789503604 VerSys Femoral Head Provisional 36mm +7 00789503605 VerSys Femoral Head Provisional 36mm +10.5 12/14 Neck Taper The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty. All lots distributed from lot 69998600 (2/20/1996) to present Class II Zimmer is in the process of enhancing the surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. These enhancements inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. The observed rate of occurrence for this type of event is approximately 0.001% or 1 in every 100,000 surgeries performed. Zimmer, Inc.
Devices 00789504001 VerSys Femoral Head Provisional 40mm -3.5 00789504002 VerSys Femoral Head Provisional 40mm +0 00789504003 VerSys Femoral Head Provisional 40mm +3.5 00789504004 VerSys Femoral Head Provisional 40mm +7 00789504005 VerSys Femoral Head Provisional 40mm +10.5 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty All lots distributed from lot 69998600 (2/20/1996) to present Class II Zimmer is in the process of enhancing the surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. These enhancements inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. The observed rate of occurrence for this type of event is approximately 0.001% or 1 in every 100,000 surgeries performed. Zimmer, Inc.
Devices 00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS 12/14 Slotted Femoral Head Provisional +0X22 00780302203 MIS 12/14 Slotted Femoral Head Provisional +3.5X22 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty All lots distributed from lot 69998600 (2/20/1996) to present Class II Zimmer is in the process of enhancing the surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. These enhancements inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. The observed rate of occurrence for this type of event is approximately 0.001% or 1 in every 100,000 surgeries performed. Zimmer, Inc.
Devices 00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 MIS 12/14 Slotted Femoral Head Provisional +0X26 00780302603 MIS 12/14 Slotted Femoral Head Provisional +3.5X26 00780302604 MIS 12/14 Slotted Femoral Head Provisional +7X26 00780302605 MIS 12/14 Slotted Femoral Head Provisional +10.5X26 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty. All lots distributed from lot 69998600 (2/20/1996) to present Class II Zimmer is in the process of enhancing the surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. These enhancements inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. The observed rate of occurrence for this type of event is approximately 0.001% or 1 in every 100,000 surgeries performed. Zimmer, Inc.
Devices 00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 MIS 12/14 Slotted Femoral Head Provisional +0X28 00780302803 MIS 12/14 Slotted Femoral Head Provisional +3.5X28 00780302804 MIS 12/14 Slotted Femoral Head Provisional +7X28 00780302805 MIS 12/14 Slotted Femoral Head Provisional +10.5X28 00780302814 MIS 12/14 Slotted Femoral Head Provisional +7X28 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty. All lots distributed from lot 69998600 (2/20/1996) to present Class II Zimmer is in the process of enhancing the surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. These enhancements inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. The observed rate of occurrence for this type of event is approximately 0.001% or 1 in every 100,000 surgeries performed. Zimmer, Inc.
Devices 00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14 Slotted Femoral Head Provisional +0X32 00780303203 MIS 12/14 Slotted Femoral Head Provisional +3.5X32 00780303204 MIS 12/14 Slotted Femoral Head Provisional +7X32 00780303205 MIS 12/14 Slotted Femoral Head Provisional +10.5X32 00780303214 MIS 12/14 Slotted Femoral Head Provisional +7X32 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty. All lots distributed from lot 69998600 (2/20/1996) to present Class II Zimmer is in the process of enhancing the surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. These enhancements inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. The observed rate of occurrence for this type of event is approximately 0.001% or 1 in every 100,000 surgeries performed. Zimmer, Inc.
Devices 00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780303603 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780303604 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780303605 MIS 12/14 Slotted Femoral Head Provisional +10.5X36 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty. All lots distributed from lot 69998600 (2/20/1996) to present Class II Zimmer is in the process of enhancing the surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. These enhancements inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. The observed rate of occurrence for this type of event is approximately 0.001% or 1 in every 100,000 surgeries performed. Zimmer, Inc.
Devices 00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780304003 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780304004 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780304005 MIS 12/14 Slotted Femoral Head Provisional +10.5X36 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty. All lots distributed from lot 69998600 (2/20/1996) to present Class II Zimmer is in the process of enhancing the surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. These enhancements inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. The observed rate of occurrence for this type of event is approximately 0.001% or 1 in every 100,000 surgeries performed. Zimmer, Inc.
Devices S-Lift Implant Guides (also known as S-LIF) Compressor Part Number: 11-50223 Product Usage: Surgical Guides allow a surgeon to place implants into tight spaces, such as a vertebral disc space, without having the implant contact the surrounding bone or tissue. In the case of S-LIFT Implant Guides, they are used to place vertebral bodies into the disc space without the body contacting the superior or inferior vertebrae. Lot Numbers: 012064-001 Class II When using the optional S-LIFT (also known as S-LIF) Implant Guides without stops, there is a known risk of moving the Implant Guides, and possibly the implant, too far into the disc space creating the potential for injury to the patient. The instructions for Use for the S-Lift Implant Guides will be amended to add the following warning: "Care is to be taken to not over insert the Implant Guides past the disc space as this could result in the possible misplacement of the implant and/or possible harm to the patient." SpineFrontier, Inc.
Devices "***SENTINEL***Cannulated Drill Bit***S8580***8 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2012-03***". This drill bit is an eccentric mono-fluted cutting edge for drilling bone tunnels in ACL and PCL reconstruction. S8580 (8.0MM Drill Bit), lot numbers 322225 and 322226 Class II Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling the S8580, 8.0MM SENTINEL Cannulated Drill Bit, lot numbers 322225 and 322226; and the S8585, 8.5MM SENTINEL Cannulated Drill Bit, lot number 322287. Recall was initiated due to the incorrect labeling on package. Linvatec Corp. dba ConMed Linvatec
Devices "***SENTINEL***Cannulated Drill Bit***S8585***8.5 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2009-02***". This drill bit is an eccentric mono-fluted cutting edge for drilling bone tunnels in ACL and PCL reconstruction. S8585 (8.5MM Drill Bit), lot number 322287 Class II Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling the S8580, 8.0MM SENTINEL Cannulated Drill Bit, lot numbers 322225 and 322226; and the S8585, 8.5MM SENTINEL Cannulated Drill Bit, lot number 322287. Recall was initiated due to the incorrect labeling on package. Linvatec Corp. dba ConMed Linvatec
Devices Multipolar® Bipolar Cup Liner 22 mm LD.; Item 00-5001-040-22 Product Usage: The liner snaps into the Multipolar® Bipolar Cup and serves as the articulation surface for the femoral head. The split poly locking ring helps contain the head within the liner and also provides a popping sound as conformation that the femoral head has completed seated, as noted in surgical technique 97-5003-003-00 Item 00-5001-040- 22; Lot 61261192, 61261194, 61296091, Class II Zimmer Inc. is initiating a removal of the Multipolar® Bipolar Cup Liner 22 mm J.D. (item 00-5001-040-22) due to reports that the split poly ring was incorrectly assembled. Zimmer, Inc.
Devices Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves as the articular surface for a femoral head in total hip arthroplasty. Item 00-6334-062-36, Lot 62023769 Class II Trilogy Longevity Constrained Liner devices were packaged in incorrect cartons. The product is packaged in the incorrect carton. Product labels and patient labels are correct, matching the product inside the carton. Zimmer, Inc.
Veterinary PEACHEY'S 20/20 AM NM MILK REPLACER,"ALL MILK", Manufactured for: Peachey's 638 Bunker Hill Road, Belleville, PA #122, NET WEIGHT 50 LBS (22.7Kg). 100222 Class I Quality Feed. Inc. is recalling milk replacer that was shipped between January 31, 2012 and March 31, 2012 because it has the potential to be contaminated with Salmonella. Quality Feed, Inc
Veterinary YO-MOMMA 26/24 AM NM MILK REPLACER., Manufactured for Agri Support Inc., 8137 Royal Oaks Road, Rockford, IL 61107 #126, NET WEIGHT 50 LBS (22.7 Kg). 070307-080308 Class I Quality Feed. Inc. is recalling milk replacer that was shipped between January 31, 2012 and March 31, 2012 because it has the potential to be contaminated with Salmonella. Quality Feed, Inc
Veterinary QUALITY FEEDS INCORPORATED 20/20 AM, ., Manufactured for Quality Feed, Inc., 151 S. Main Street, Dousman, WI 53118 Pin #2021, NET WEIGHT 50 LBS (22.7 Kg). 070124-080124; 010127-030127; 010131-020131; 100207; 020216; 120220-130220; 100220-110220; 050227-070227; 040308-070308; 060314-070314; and 070321-080321 Class I Quality Feed. Inc. is recalling milk replacer that was shipped between January 31, 2012 and March 31, 2012 because it has the potential to be contaminated with Salmonella. Quality Feed, Inc
Veterinary DAIRY PRINCESS "ACCELERATED" , 23/18 AM MILK REPLACER MEDICATED, Manufactured for Nelson Dairy Consultants, Inc., Holtz Nelson Dairy Consultants, LLC., 115 Washington Street, Decorah, IA 52101 #208, NET WEIGHT 50 LBS (22.7 Kg). 010307-040307 and 010309 Class I Quality Feed. Inc. is recalling milk replacer that was shipped between January 31, 2012 and March 31, 2012 because it has the potential to be contaminated with Salmonella. Quality Feed, Inc
Veterinary QUALITY FEED INC., STARTER PLUS, 20/17 , MILK REPLACER, Manufactured by Quality Feed, Inc., 151 S. Main Street, Dousman, WI 53118, NET WEIGHT 50 LBS (22.7 Kg). 040127-060127; 030206-040206; 040220-060220; 050302; and 010227-040227 Class I Quality Feed. Inc. is recalling milk replacer that was shipped between January 31, 2012 and March 31, 2012 because it has the potential to be contaminated with Salmonella. Quality Feed, Inc
Veterinary QUALITY FEED INC., FINISHER PLUS 16/18 , MILK REPLACER , Manufactured by Quality Feed, Inc., 151 S. Main Street, Dousman, WI 53118, NET WEIGHT 50 LBS (22.7 Kg). 030201-060201; 010202-020202; 050206-080206; 010221-040221; 060223-110223; 010224-100224; 010228-100228; 050229-090229; 010301-050301; 060301-150301; 010313-080313; 010315-080315; 010321-040321; 090321-120321; 010322-100322; 010229-040229; and 050222-080222 Class I Quality Feed. Inc. is recalling milk replacer that was shipped between January 31, 2012 and March 31, 2012 because it has the potential to be contaminated with Salmonella. Quality Feed, Inc
Drugs HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-3888-21 Lot number: C1440512A, Exp 12/13 Class I Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components. Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
Devices Spine Frontier Inspan compressors Part Number: 11-60004. Inspan compressors provide pressure to drive spikes of Inspan implants into the spinous process bone, resulting in fixation of the implant. Lot Numbers: SFP02323, SFP02323R, and SFP02323RR Class II Inspan Compressors may break at weld causing a loss of compression SpineFrontier, Inc.
Biologics Red Blood Cells Leukocytes Reduced W042212029384G Class II Blood product, which did not meet the acceptable product specifications, was distributed. Blood Systems, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W038112119947 Class III Blood product, which may have been exposed to unacceptable temperature during storage, was distributed. Florida's Blood Centers, Inc.
Biologics Source Plasma GA1468179; GA1468692; GA1469352; Class II Blood products, which were not quarantined subsequent to receiving post- donations information, were distributed. DCI Biologicals LLC
Biologics Red Blood Cells W141611418327 Class II Blood product, collected from a therapeutic donor and not labeled to indicate the type of donation, was distributed. Puget Sound Blood Center and Program
Biologics Red Blood Cells Leukocytes Reduced W035412058570 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Center
Biologics Blood and Blood Products for Reprocessing W035412058570 Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Center
Biologics Blood and Blood Products for Reprocessing W070511610907; W070511714151 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Stanford Medical School Blood Center
Biologics Red Blood Cells Leukocytes Reduced W041012095914Y Class II Blood products, which were not quarantined subsequent to receiving information regarding a post donation illness, were distributed. Blood Systems Inc
Biologics Red Blood Cells Leukocytes Reduced W142812407280U Class II Blood product, collected from a donor who may be at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed. Tri-counties Blood Bank
Drugs Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured By: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 00591-0540-05. Lot #: 519406A, 521759A, Exp 04/14 Class I Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets. Watson Laboratories Inc
Biologics Cryoprecipitated AHF W036312921763; W036312921762; W036312922130; W036312922129; W036312922234; W036312922233; W036312922230; W036312922229; W036312922232; W036312922231 Class III Blood products, not prepared according to specifications, were distributed. BloodCenter of Wisconsin, Inc
Biologics Platelets Pheresis Leukocytes Reduced W051512093782 (part A); W051512093782 (part B); W051512093782 (part C) Class II Blood products, which did not meet the acceptable product specifications, were distributed. Memorial Blood Centers
Biologics Red Blood Cells Leukocytes Reduced W041112038759Q Class II Blood product, left in shipping container and was exposed to unacceptable temperatures, was distributed. Blood Systems, Inc
Devices Mindray A3 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a device used to administer to a patient continuously or intermittently a general inhalation anesthetic and to maintain a patient's ventilation. 0633F-01000-00 Various serial numbers 0633F-01000-00 FA-1A000033 0633F-01000-00 FA-1A000023 0633F-01000-00 FA-21000072 0633F-01000-00 FA-1A000029 0633F-01000-00 FA-21000085 0633F-01000-00 FA-19000011 0633F-01000-00 FA-19000008 0633F-01000-00 FA-19000009 0633F-01000-00 FA-1A000027 0633F-01000-00 FA-1A000047 0633F-01000-00 FA-1A000055 0633F-01000-00 FA-1A000041 0633F-01000-00 FA-1A000053 0633F-01000-00 FA-1B000056 0633F-01000-00 FA-21000080 0633F-01000-00 FA-19000007 0633F-01000-00 FA-19000013 0633F-01000-00 FA-21000066 0633F-01000-00 FA-21000078 0633F-01000-00 FA-19000012 0633F-01000-00 FA-19000017 0633F-01000-00 FA-1A000021 0633F-01000-00 FA-1A000028 0633F-01000-00 FA-1A000038 0633F-01000-00 FA-1A000045 0633F-01000-00 FA-1A000035 0633F-01000-00 FA-1A000037 0633F-01000-00 FA-1A000026 0633F-01000-00 FA-1A000030 0633F-01000-00 FA-1A000048 0633F-01000-00 FA-1A000040 0633F-01000-00 FA-1B000059 0633F-01000-00 FA-1A000034 0633F-01000-00 FA-1A000049 0633F-01000-00 FA-21000062 0633F-01000-00 FA-21000064 0633F-01000-00 FA-21000074 0633F-01000-00 FA-21000082 0633F-01000-00 FA-21000090 0633F-01000-00 FA-1A000022 0633F-01000-00 FA-1A000051 0633F-01000-00 FA-1A000052 0633F-01000-00 FA-1A000042 0633F-01000-00 FA-1A000050 0633F-01000-00 FA-1B000057 0633F-01000-00 FA-1B000061 0633F-01000-00 FA-1A000025 0633F-01000-00  ...
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Class I Mindray has identified the potential for a system leak resulting an issue related to the carbon dioxide absorber canister gasket on A3/A5 Anesthesia Delivery Systems. A potential system leak resulting from the canister gasket will likely present itself during the Automatic Circuit Leak and Compliance Test performed at startup and the Manual Leak Test recommended to be performed before each case. Mindray DS USA, Inc. d.b.a. Mindray North America
Devices Mindray A5 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a device used to administer to a patient continuously or intermittently a general inhalation anesthetic and to maintain a patient's ventilation. 0631F-01000-00 Various serial numbers 0631F-01000-00 EJ-1A001411  ...
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Class I Mindray has identified the potential for a system leak resulting an issue related to the carbon dioxide absorber canister gasket on A3/A5 Anesthesia Delivery Systems. A potential system leak resulting from the canister gasket will likely present itself during the Automatic Circuit Leak and Compliance Test performed at startup and the Manual Leak Test recommended to be performed before each case. Mindray DS USA, Inc. d.b.a. Mindray North America
Devices ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed by ETHICON ETHICON Inc. Somerville, NJ 08876 USA Ref 2993 SURGIFLO Hemostatic Matrix, mixed with sterile saline or thrombin solution, is indicated for surgical procedures (except ophthalmic) for hemostasis, when control of capillary, venous and arteriolar bleeding by pressure, ligature, and other conventional procedures is ineffective or impractical. This is a topical absorbable hemostat consisting of a flowable gelatin matrix (paste) and a lyophilized Thrombin component. This kit also contains components necessary for preparing and applying the matrix during surgery. PMA: P990004 Medical Device Listing Number: D100622 Product Code 2993 Lot/Batch Numbers: 239346 Exp Jan-13 239411 Exp Jun-13 Class I SURGIFLO Hemostatic Matrix Kit & SURGIFLO Hemostatic Matrix Kit with Thrombin have an issue within the packing process where a cut could potentially breach the double Tyvek pouch of the packaging. Ethicon, Inc.
Devices ETHICON SURGIFLO HEMOSTATIC MATRIX Distributed by ETHICON ETHICON, Inc. Somerville, NJ 08876, USA SURGIFLO Hemostatic Matrix is a topical absorbable hemostat consisting of a flowable gelatin matrix (paste). This kit also contains components necessary for preparing and applying the matrix during surgery. SURGIFLO Hemostatic Matrix, mixed with sterile saline or thrombin solution, is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or other conventional methods is ineffective or impractical. PMA number P990004 Medical Device Listing Number D100622 Product Code: 2991 Lot # 239091 Exp Mar-13 Lot # 238783 Exp Sep-13 Lot # 238635 Exp Mar-13 Lot # 237498 Exp Mar-13 Lot # 237119 Exp Mar-13 Lot # 235488 Exp Jan-13 Class I SURGIFLO Hemostatic Matrix Kit & SURGIFLO Hemostatic Matrix Kit with Thrombin have an issue within the packing process where a cut could potentially breach the double Tyvek pouch of the packaging. Ethicon, Inc.
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 004GJ51699; 004GJ51699; 004GJ51699; 004GJ51700; 004GJ51700; Class III Blood products, with incorrectly transcribed platelet counts, were distributed. Arc Blood Services, New England Region
Biologics Platelets Pheresis Leukocytes Reduced 004GJ51698; 004GJ51698; 004GJ51698; 04GZ09699; 004GZ09699; Class III Blood products, with incorrectly transcribed platelet counts, were distributed. Arc Blood Services, New England Region
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W068512006765I; Class II Blood product, which did not meet the acceptable product specifications for release, was distributed. Inland Northwest Blood Center
Devices Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6525-1 The 6.5mm Cancellous Bone Screws are used in THA when the surgeon elects to use a cluster/multi-hole shell in the acetabulum. The screws are intended to provide initial cup fixation and help prevent spin-out of the cup due to physical loading from the patient. They are intended as supplemental fixation. Catalog No: 2030-6525-1 Lot Code: MLHYL7, MLJT50 Ref 2030-6525-1 Class II Stryker has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone Screws are either associated with a product mix or potentially associated with a product mix. Packaging associated with a 35 mm screw may contain a 25mm screw. Conversely, packaging associated with a 25mm screw may contain a 35mm screw. Stryker Howmedica Osteonics Corp.
Devices Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6535-1 The 6.5mm Cancellous Bone Screws are used in THA when the surgeon elects to use a cluster/multi-hole shell in the acetabulum. The screws are intended to provide initial cup fixation and help prevent spin-out of the cup due to physical loading from the patient. They are intended as supplemental fixation. Catalog No: 2030-6535-1 Lot Code: MLDNAV, MLDXV2, MLH11M, MLH17R, MLH3K8, MLH4L6, MLH7RV, MLHK1X, MLHL99, MLJDJT Ref 2030-6535-1 Class II Stryker has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone Screws are either associated with a product mix or potentially associated with a product mix. Packaging associated with a 35 mm screw may contain a 25mm screw. Conversely, packaging associated with a 25mm screw may contain a 35mm screw. Stryker Howmedica Osteonics Corp.
Devices Stryker XIA 3 TORQUE WRENCH REF 48237028 Manufactured by: Stryker pine SAS Z.I MARTICOT-33610-CESTAS-FRANCE +33 (0)5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine, 2 Pearl Ct. Allendale NJ 07401-1677 USA +1-201-780-8000 The Xia 3/Mantis Redux/Specialty Audible Torque Wrenches are used to final tighten the blocker of the Xia 3/ Mantis Redux Polyaxial Screws, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors. The Torque Wrench is a t-handle deflection beam torque wrench with a 5 mm hex tip. The instrument allows the controlled application of 12 Nm torque via a visual indicator on the bell shaped cylinder just below the handle. The Specialty Audible Torque Wrench has an extra feature where it creates and audible "click" when the desired final tightening torque is reached. Class I device, 510(K) exempt Catalog Number: 48237028 Lot Number: 093653, 093654, 093655 Class II Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening. Stryker Spine
Devices Stryker MANTIS TORQUE WRENCH REF 48287028 Manufactured by: Stryker pine SAS Z.I MARTICOT-33610-CESTAS-FRANCE +33 (0)5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine, 2 Pearl Ct. Allendale NJ 07401-1677 USA +1-201-780-8000 The Xia 3/Mantis Redux/Specialty Audible Torque Wrenches are used to final tighten the blocker of the Xia 3/ Mantis Redux Polyaxial Screws, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors. The Torque Wrench is a t-handle deflection beam torque wrench with a 5 mm hex tip. The instrument allows the controlled application of 12 Nm torque via a visual indicator on the bell shaped cylinder just below the handle. The Specialty Audible Torque Wrench has an extra feature where it creates and audible "click" when the desired final tightening torque is reached. Class I device, 510(K) exempt Catalog Number: 48287028 Lot Number: 098400 Class II Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening. Stryker Spine
Devices SPECIALTY AUDIBLE TORQUE WRENCH, XIA IS2217XLP MFG BY: STRYKER SPINE 2 PEARL COURT ALLENDALE NJ 07401-1677 The Xia 3/Mantis Redux/Specialty Audible Torque Wrenches are used to final tighten the blocker of the Xia 3/ Mantis Redux Polyaxial Screws, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors. The Torque Wrench is a t-handle deflection beam torque wrench with a 5 mm hex tip. The instrument allows the controlled application of 12 Nm torque via a visual indicator on the bell shaped cylinder just below the handle. The Specialty Audible Torque Wrench has an extra feature where it creates and audible "click" when the desired final tightening torque is reached. Class I device, 510(K) exempt Catalog Number: IS2217XLP Lot Number: 2576, 2756 Class II Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening. Stryker Spine
Devices bioMerieux BacT/ALERT Control Module, catalog number 210147, Clinical instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. Identified by B.40 firmware Class II The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Biomerieux Inc
Devices bioMerieux BacT/ALERT Combo Module, catalog number, 200290, Clinical instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. Identified by B.40 firmware Class II The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Biomerieux Inc
Devices bioMerieux BacT/ALERT 3D 60, catalog number, 248009, Clinical instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. Identified by B.40 firmware Class II The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Biomerieux Inc
Devices bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML01, Clinical instrument software, English, Spanish, Italian, catalog number 411814 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. Identified by B.40 firmware Class II The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Biomerieux Inc
Devices bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML 02, Clinical instrument software, English, Spanish, Italian, catalog number 411815 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. Identified by B.40 firmware Class II The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Biomerieux Inc
Devices bioMerieux Kit, Instrument & Update, 3D B.40 BTA3D-ZH01, Clinical instrument software, Chinese, catalog number 411816 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. Identified by B.40 firmware Class II The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Biomerieux Inc
Devices bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML03, Clinical instrument software, Danish, Greek, Polish, Portuguese, catalog number 412623 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. Identified by B.40 firmware Class II The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Biomerieux Inc
Devices bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML04, Clinical instrument software, Czech, Estonian, Hungarian, Romanian, catalog number 412624 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. Identified by B.40 firmware Class II The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Biomerieux Inc
Devices bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML05, Clinical instrument software, Lithuanian, Latvian, Russian, Slovak, catalog number 412625 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. Identified by B.40 firmware Class II The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Biomerieux Inc
Devices bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML06, Clinical instrument software, Japanese, Korean, Norwegian, Brazilian, Portuguese, Turkish, catalog number 412626 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. Identified by B.40 firmware Class II The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Biomerieux Inc
Devices bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML01, Clinical instrument software, English, Spanish, Italian, catalog number 411818 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. Identified by B.40 firmware Class II The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Biomerieux Inc
Devices bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML02, Clinical instrument software, German, French, Swedish, catalog number 411925 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. Identified by B.40 firmware Class II The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Biomerieux Inc
Devices bioMerieux Kit, USB HDW, BTA3D60-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411956 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. Identified by B.40 firmware Class II The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Biomerieux Inc
Devices bioMerieux Kit, USB HDW, BTA3D COMBO-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411957 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. Identified by B.40 firmware Class II The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Biomerieux Inc
Devices bioMerieux Kit, USB HDW, BTA3D CONTROL-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411958 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. Identified by B.40 firmware Class II The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Biomerieux Inc
Devices bioMerieux Kit, USB Instrument & Update, 3D B.40 USB-ML03, Clinical instrument software, Danish, Greek, Polish, Portuguese, catalog number 412559 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. Identified by B.40 firmware Class II The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Biomerieux Inc
Devices bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML04, Clinical instrument software, Czech, Estonian, Hungarian, Romanian, catalog number 412620 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. Identified by B.40 firmware Class II The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Biomerieux Inc
Devices bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML05, Clinical instrument software, Lithuanian, Latvian, Russian, Slovak, catalog number 412621 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. Identified by B.40 firmware Class II The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Biomerieux Inc
Devices bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML06, Clinical instrument software, Japanese, Korean, Norwegian, Brazilian, Portuguese, Turkish, catalog number 412622 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. Identified by B.40 firmware Class II The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Biomerieux Inc
Devices bioMerieux BacT/ALERT Control Module, catalog number 210148, Industrial instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. Identified by B.40 firmware Class II The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Biomerieux Inc
Devices bioMerieux BacT/ALERT Combo Module, catalog number 200291, Industrial instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. Identified by B.40 firmware Class II The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Biomerieux Inc
Devices bioMerieux BacT/ALERT Combo Module, catalog number 247014, Industrial instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. Identified by B.40 firmware Class II The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Biomerieux Inc
Devices bioMerieux Kit, Instrument & Update, 3D IND ZIP-ML 01, Industry instrument software update, English, Spanish, Italian, catalog number 412005 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. Identified by B.40 firmware Class II The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Biomerieux Inc
Devices bioMerieux Kit, Instrument & Update, 3D IND USB-ML 02, Industry instrument software update, English, Spanish, Italian, catalog number 412006 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. Identified by B.40 firmware Class II The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Biomerieux Inc
Devices bioMerieux Kit, Instrument & Update, B.40 Dualt-ML, Industry instrument software update, English, Spanish, Italian, German, French, Japanese, Brazilian, Portuguese, catalog number 412950 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. Identified by B.40 firmware Class II The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Biomerieux Inc
Devices bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 412002 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. Identified by B.40 firmware Class II The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Biomerieux Inc
Devices bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML02, Industry instrument software update, German, French, catalog number 412003 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. Identified by B.40 firmware Class II The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Biomerieux Inc
Devices bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 413481 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. Identified by B.40 firmware Class II The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Biomerieux Inc
Devices bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML02, Industry instrument software update, German, French, catalog number 413482 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. Identified by B.40 firmware Class II The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Biomerieux Inc
Devices bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 413483 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. Identified by B.40 firmware Class II The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Biomerieux Inc
Devices bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML02, Industry instrument software update, English, Spanish, Italian, catalog number 413484 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. Identified by B.40 firmware Class II The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Biomerieux Inc
Devices 0.9% Sodium Chloride Injections, USP, 1000ml, VWR/Baxter Product Usage: The concentrated sodium chloride is used to prepare inoculum that is analyzed by the VITEK 2 instrument. The VITEK 2 user manual instructs all users to prepare inoculum with 0.45%-0.50% sodium chloride injections, and the system is designed to use 0.45%-0.50% sodium chloride concentration only. Lot number C866715, EXP OCT 13 Class II The firm inventoried and distributed 0.9% Sodium Chloride Saline bags as 0.45% Sodium Chloride Saline bags for use with the VITEK 2 system. Biomerieux Inc
Devices Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor and delivery. Lot #S03123 Model #7000AA0 Class II Thirty fetal scalp electrodes were found to have an incomplete package seal and lacked the printed lot number stamped on during sealing. Vital Signs Devices, a GE Healthcare Company
Food Dannon Activia LIGHT Nonfat Yogurt Peach Flavor, Each unit 4-pack of 4-oz cups/6, 4-count pack to a case (24 cups/case) UPC 3663202633 Expiration Code NOV 07 2012 MZ, Expiration Code NOV 09 2012 MZ, Expiration Code NOV 10 2012 MZ Class II Not labeled correctly The Dannon Company Inc
Food Gilster-Mary Lee Corporation, Better Valu Fruit Whirls, Naturally Flavored packaged in a 28 oz (1 LB 12 OZ) (794g) plastic bag. (manufactured by Gilster Mary Lee, Joplin, MO) Bag label: UPC 79801-24630 Best Buy Code: JUL 17 13 J8 Case label: UPC 79801-24632 Best Buy Code: JUL 17 13 JB Class I The Better Valu Fruit Whirls contain undeclared almond butter. Gilster-Mary Lee Corp.
Devices IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used in both the Neuro II-SE and Neuro III-SV Magnetic Resonance Imaging Systems. 10002845, 10002341, 10003244, 10002794, 10003243, 10003629, 10003801, 10002654, 10002796, 10002795, 10002846, 10002847, 10003830, 10003064, 10005201,10003754, 10004513 Class II IMRIS Inc. initiated a recall of their OR Tables ORT100 and ORT200. When proper procedure is not followed, the foot end of the IMRIS intra-operative OR table may be attracted to the MRI magnet as the magnet approaches the table. This poses a potential risk of injury to both the patient and operators standing near the table. Innovative Magnetic Resonance Imaging Systems Inc.
Food Salted in-shell Peanuts under the following. Salted in Shell PeanutsGless Ranch Label, Item Number 450-175, Pack Size 24/12 oz bags, UPC Code 72488980310. Salted in Shell PeanutsSun Harvest Label, Item Number 450-248, Pack Size 24/16 oz bags, UPC Code 646670306785. Salted in-shell Peanuts, Item Number 450-195, 50 lb Bulk Bag, UPC Code none. Salted in-shell PeanutsTorn and Glasser bulk case, Item Number 450-185, 25 lb Bulk Case, UPC Code none. Salted in-shell PeanutsTorn and Glasser retail label, Item Number 450-245, Pack Size 24/1 lb, UPC Code 72488858664. Salted in Shell PeanutsSprouts label, Item Number SP450-185, Pack Size 25 lb case/12bags, UPC Code 206561XXXXXX (last 6numbers change for each package -random weight). Salted in Shell Peanuts Gless Ranch Label. Lots: 0112; 0522; 0932. Lot code marking can be found on the front label. Salted in Shell Peanuts Sun Harvest Label. Best by Dates: 06/16/12; 05/09/12; 08/13/12; 07/08/12; 09/09/12; 10/22/12; 11/18/12; 11/26/12; 12/12/12; 02/05/13; 03/24/13; 03/30/13. Lot code marking can be found on the back corner next to the seal. Salted in-shell Peanuts.  ...
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Class I Torn and Glasser, Inc of Los Angeles, CA 90021 is voluntarily recalling Salted in-shell product (packaged after November 9, 2011), and one lot of Organic Peanut Butter (packaged January 13, 2012) because they contain recalled peanuts and peanut butter received from Sunland, Inc., and have the potential to be contaminated with Salmonella, Torn & Glasser Inc.
Food Organic Peanut Butter, Item Number 342-007, Pack size 12/14oz tubs. No UPC code. Product labeling:" ". Lot 0132 (produced January 13, 2012). Lot code marking can be found on the side label. Class I Torn and Glasser, Inc of Los Angeles, CA 90021 is voluntarily recalling Salted in-shell product (packaged after November 9, 2011), and one lot of Organic Peanut Butter (packaged January 13, 2012) because they contain recalled peanuts and peanut butter received from Sunland, Inc., and have the potential to be contaminated with Salmonella, Torn & Glasser Inc.
Devices qube Compact Monitor (Patient Monitor) 91390. The monitor is 26.2 cm x 31.5 cm x 13.2 cm and weighs 4.1 kg (10.3 inches x 12.4 inches x 5.2 inches - 9 lbs). It has a 26.2 cm (12.1 inches) LCD display with 1024 x 768 resolution. The Spacelabs Healthcare Qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by 2 Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECU, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed. The Qube is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. The Qube may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitors allow network-based applications to open windows and display information on other networked monitors. The Qube is also designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders. The Qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment. Serial numbers for devices distributed in the US: 1390-000102, 1390-000103, 1390-000104, 1390-000105, 1390-000106, 1390-000107, 1390-000108, 1390-000109, 1390-000110, 1390-000111, 1390-000112, 1390-000113, 1390-000114, 1390-000115, 1390-000116, 1390-000119, 1390-000120, 1390-000150, 1390-000151, 1390-000152, 1390-000153, 1390-000154, 1390-000155, 1390-000156, 1390-000157, 1390-000158, 1390-000159, 1390-000160, 1390-000161, 1390-000162, 1390-000163, 1390-000164, 1390-000165, 1390-000166, 1390-000167, 1390-000168, 1390-000169, 1390-000170, 1390-000171, 1390-000172, 1390-000173, 1390-000174,  ...
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Class II Spacelabs Healthcare has learned through several reports that the input circuit may fail and the monitor will go on battery mode. The monitor will function normally until the batteries become depleted and then the monitor will shut down. In addition the monitor may fail to turn on due to an internal short. Spacelabs Healthcare, Llc
Devices UniCel Dxl 800 Access Immunoassay System, Part Numbers: 973100, A71456, and A71457. The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The UniCel DxC series of instruments is a DxI Immunoassay System integrated with a chemistry analyzer. Serial Numbers: 600000 through 602389 Class II The recall was initiated because Beckman Coulter has confirmed that the UniCel Dxl and DxC Access Immunoassay Systems had field modifications to the aspirate and dispense probe assemblies. Beckman Coulter Inc.
Devices UniCel Dxl 600 Access Immunoassay System, Part Numbers: A30260, A71460, and A71461. The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The UniCel DxC series of instruments is a DxI Immunoassay System integrated with a chemistry analyzer. Serial Numbers: 900000 through 900491. Class II The recall was initiated because Beckman Coulter has confirmed that the UniCel Dxl and DxC Access Immunoassay Systems had field modifications to the aspirate and dispense probe assemblies. Beckman Coulter Inc.
Devices UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems, Part Numbers: A64871, A64903, A64935, A59102. The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The UniCel DxC series of instruments is a DxI Immunoassay System integrated with a chemistry analyzer. Serial Numbers: Included in the corresponding Dxl system. Class II The recall was initiated because Beckman Coulter has confirmed that the UniCel Dxl and DxC Access Immunoassay Systems had field modifications to the aspirate and dispense probe assemblies. Beckman Coulter Inc.
Devices Freedom Cordless LED Light System. Freedom System, Standard Length, Part Number 910863-1, Serial Numbers 77001000-77003470 and Freedom System, Long Length, Part Number 910863-2, Serial Numbers 77001000-77003470. Freedom Cordless LED Light System is a Class I Medical Device. The device listing number this product is E115952. The intended use of this device is to illuminate oral structures and operating areas. Freedom System, Standard Length, Part Number 910863-1, Serial Numbers 77001000-77003470 and Freedom System, Long Length, Part Number 910863-2, Serial Numbers 77001000-77003470. Freedom Cordless LED Light System has no expiration date. The affected units were produced and distributed since February 2011. Class II The firm recalled the Freedom Cordless LED Headlight because some units were assembled with an incorrect component in the control board electronics that may cause some Freedom Cordless LED Headlight units to become warm to the touch; however, no skin damage will occur. Kerr Corporation
Devices The brand name of the device is Laser Loupes, a dentalloupe with laser eye protection. Laser Loupes have been assigned product code 79 FSP and are classified as a Class I Medical Devices. Laser Loupes are available with four (4) different filters of different colors. Each colored filter is associated with specific laser frequency ranges. The device listing number for this product is E160359. The intended use of this device is to magnify the operatory field and provide laser eye protection. The Laser Loupes are custom made-to-order products. There are no general model, catalog, code, lot or serial numbers. Laser Loupes have no expiration date. The affected units were produced and distributed since September 2008. Class II The firm initiated the recall for Laser Loupes because the ink used to mark which laser frequency each laser Loupe protects against may wipe off. The loupes work according to specification, but the marking may not permanently adhere to the device. Kerr Corporation
Food Rudi's Organic Bakery, Colorado Cracked Wheat, 22 oz, UPC 031493-54373-6, packed in flexible plastic bags. Labeling is tan, yellow, white, maroon, and orange with white, black, green, maroon, and orange print writing. Lot Code: 2-193-R. Class II Rudi's Organic Bakery is voluntarily recalling select packages of Rudi's Organic Bakery bread loaves due to the possible presence of small metal objects. Charter Baking Company
Food Rudi's Organic Bakery, Multigrain Oat Bread, 22 oz, UPC 031493-82888-8, packed in flexible plastic bags. Labeling is tan, yellow, white, maroon, and orange with maroon, green, black, white, and orange print writing. Lot Code: 1-173-R. Class II Rudi's Organic Bakery is voluntarily recalling select packages of Rudi's Organic Bakery bread loaves due to the possible presence of small metal objects. Charter Baking Company
Food Rudi's Organic Bakery, Cinnamon Raisin, 24 oz, UPC 031493-92183-1, packed in flexible plastic bags. Labeling is tan, yellow, white, blue, maroon, and orange with white, black, green, maroon, and orange print writing. Lot Code: 1-273-R. Class II Rudi's Organic Bakery is voluntarily recalling select packages of Rudi's Organic Bakery bread loaves due to the possible presence of small metal objects. Charter Baking Company
Drugs Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325, India NDC 55111-249-05 Lot C203090 Exp.03/14 Class II Failed USP Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg. Dr. Reddy's Laboratories, Inc.
Devices Vital Signs Disposable General Purpose 9 French Temperature Probe For monitoring of core temperature Model Numbers 1016, 1016EU, R1016ES; GXXXX64 All units Made in Costa Rica are affected Lot Numbers: 12089A 12131A 5575A 5586X 5633U 5664E 5685G 5712T 12090B 12138A 5578K 5603R 5636Y 5666R 5685H 5714Z 12100A 12157B 5578L 5606U 5638P 5668N 5685J 12101B 12173A 5580Y 5614N 5638Q 5669G 5689Y 12102A 5573Q 5580Z 5615N 5648T 5669H 5691T  ...
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Class II There is a potential for epistaxis during use of the Disposable General Purpose 9 French Temperature Probe. Vital Signs Colorado Inc.
Devices Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels Low, Normal, and High). Minotrol 16 is a tri-level control intended for in vitro diagnostic use in monitoring the accuracy and precision on HORIBA Medical hematology blood cell counters using HORIBA Medical reagents. Minotrol 16 is an in vitro diagnostic reagent composed of human erythrocytes, mammalian leukocytes, and platelets in a plasma-like fluid with preservatives. Minotrol 16 is a stable material that provides a means of determining the accuracy and precision of hematology blood cell counters. It is handled in the same manner as a patient specimen. The assay tables are determined on validated instruments using the appropriate reagents Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels Low, Normal, and High). Class III HORIBA Medical Irvine Technical Support received reports from some customers that have experienced high recover values for Hemoglobin when using Minotrol 16 lot #MX090 (Level High). Customer communication was sent 10/01/2010. Horiba Instruments, Inc dba Horiba Medical
Devices The Trilogy Acetabular System Shell with Cluster Holes Porous 56 mm O.D. Sterile The Trilogy Acetabular System is indicated for either cemented or uncemented use In skeletally mature Individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused Hip, fracture of the pelvis, and diastrophic variant. The shells with screw holes permit the use of titanium alloy screws to provide additional fixation and security, particularly in those cases where acetabular bone stock is deficient. REF 6200-056-22, lot 62010615 Class II Zimmer Trilogy® Acetabular System Shell with Cluster Holes, Porous,56 MM O.D., sterile; is missing polar hole threads. Zimmer received one complaint in which no injury was reported. Zimmer, Inc.
Food Swanson Organic, 100% Certified Organic Fennel Seed, Net Wt 6 oz (45 grams), SWF092, UPC 0 87614 24092 3. 1841231C, 1071206C Class III This is to inform you of a product recall involving 2 lots of Swanson Organic 100% Certified Organic Fennel Seed (SWF092). Some jars of fennel seeds have been found to contain small, red beetle-type insects. Swanson Health Products, Inc
Drugs Limed Bone Gelatin, packaged in six 125 kg fiber drums and labeled in part PO NO.: P8095 GELATIN 75 BLOOM ITEM NO. RM 164. MADE IN INDIA Batch No. SG4704, Exp 02/22/2017. Class II Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. American Enterprises LLC dba Sterling Gelatin
Devices 4.5mm PLEO Osteotomy Guide. OrthoPediatrics Corp. markets a pediatric, extension osteotomy bone plate system. This system is marketed under the brand name OrthoPediatrics PediLock Extension Osteotomy Plate ( PLEO ). The product included in this recall is a Class I, 4.5mm PLEO Osteotomy Guide Instrument, common name: Guide, Surgical, Instrument. The PediLoc® Extension Osteotomy Plate is part of the OrthoPediatrics~PediLoc® system. The PediLoc® Extension Osteotomy Plate consists of 3.5mm and 4.5mm plates, left and right side specific. The PediLoc® Extension Osteotomy Plate is designed to fit the anatomy of the distal femur in children and adolescents, above the distal femoral physis. The distal section of the plate is designed so that three locking screws can be placed in the distal bone segment at an angle parallel to the distal femoral physis. The proximal portion of the plate is designed to accept locking or non-locking screws. The subject instrument of this recall is an adjunct instrument for the convenience of some surgeons who choose to use it. This instrument is not illustrated in the Surgical Technique, nor required to perform the procedure. Part number: 01-1050-0066 and 01-1050-0067 Lot numbers: 7861001 and 7861101 only Class II Complaint received from sales representative that the drill guide tubes would not screw into replenishment instrument. Upon investigation, it has been determined that the device was not manufactured to design specifications and will not function as intended. OrthoPediatrics Corp
Devices BioPlant, a dental bone grafting material. BioPlant has been assigned the product code LYC (Bone Grafting Material, Synthetic) by the FDA and is classified as a Class II Medical Device. BioPlant is a Class II Medical Device. The Device Listing Number is 0007254. BioPlant is a synthetic, multipurpose bone-grafting material intended to be used in dental applications to maintain and restore the bony alveolar ridge in post-extraction tooth-root sockets or after oral surgery, ridge preservation, ridge augmentation, augmentations in the maxillary sinus, repair of periodontal defects and bone voids associated with dental implant placement. The BioPlant part numbers and lot numbers affected by this recall are as follows: ÿProduct Description Part Numbers Lot Numbers SioPlant Curved Syringe, 0.125g 216110 All Production SioPlant Curved Syringe, 0.25g 216112 SioPlan! Curved Svrinoe, 0.50<1 216114 Lots Within Shelf-Life BioPlant Curved Svrinoe, 0.250 216132 20k BioPlant Intro Pack 216112S Class II The firm initiated the recall becaue disturbing the BioPlant product soon after it is placed may halt or delay the ossification process. Kerr Corporation
Devices KING LAD SILI CONE SINGLE USE, King Systems devices/case, ETO Sterile. Size 2 / Infant Silicone King LAD· Patient Size: 10-20kg Product Usage: Laryngeal airway REF: LAD-302, Lot #K120501 Class II The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO sterilization cycle. The firms investigation revealed that the complainant claims were confirmed; the firm then performed a 100% inspection of all product supplied by Three Lions Ltd. The firm segregated the affected lots of King LAD devices. King Systems Corp.
Devices KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 3 / Child Silicone King LAD· Patient Size: 30-50kg Product Usage: Laryngeal airway REF: LAD-303, Lot #K120618 Class II The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO sterilization cycle. The firms investigation revealed that the complainant claims were confirmed; the firm then performed a 100% inspection of all product supplied by Three Lions Ltd. The firm segregated the affected lots of King LAD devices. King Systems Corp.
Devices KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 4 / Adult Silicone King LAD· Patient Size: 50-70kg REF: LAD-304, Lot #K120619 Class II The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO sterilization cycle. The firms investigation revealed that the complainant claims were confirmed; the firm then performed a 100% inspection of all product supplied by Three Lions Ltd. The firm segregated the affected lots of King LAD devices. King Systems Corp.
Devices KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult Silicone King LAD· Patient Size: >70kg Product Usage: Laryngeal airway REF: LAD-305, Lot #K120620 and Lot #K120406 Class II The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO sterilization cycle. The firms investigation revealed that the complainant claims were confirmed; the firm then performed a 100% inspection of all product supplied by Three Lions Ltd. The firm segregated the affected lots of King LAD devices. King Systems Corp.
Devices KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie10 devices/case Size 3 / Child ClearSeal King LAD· Patient Size: 30-50kg Product Usage: Laryngeal airway REF: LAD-703, Lot #K120411 Class II The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO sterilization cycle. The firms investigation revealed that the complainant claims were confirmed; the firm then performed a 100% inspection of all product supplied by Three Lions Ltd. The firm segregated the affected lots of King LAD devices. King Systems Corp.
Devices KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 4 / Adult ClearSeal King LAD· Patient Size: 50-70kg Product Usage: Laryngeal airway REF: LAD-704, Lot #K120412 Class II The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO sterilization cycle. The firms investigation revealed that the complainant claims were confirmed; the firm then performed a 100% inspection of all product supplied by Three Lions Ltd. The firm segregated the affected lots of King LAD devices. King Systems Corp.
Devices KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 5 / Adult ClearSeal King LAD· Patient Size: >70kg Product Usage: Laryngeal airway REF: LAD-705, Lot #K120413 Class II The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO sterilization cycle. The firms investigation revealed that the complainant claims were confirmed; the firm then performed a 100% inspection of all product supplied by Three Lions Ltd. The firm segregated the affected lots of King LAD devices. King Systems Corp.
Devices KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size 2 / Infant ClearSeal Flexible King LAD· Patient Size: 10-20kg Product Usage: Laryngeal airway REF: LAD-902, Lot #K120414 Class II The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO sterilization cycle. The firms investigation revealed that the complainant claims were confirmed; the firm then performed a 100% inspection of all product supplied by Three Lions Ltd. The firm segregated the affected lots of King LAD devices. King Systems Corp.
Devices KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 3 / Child ClearSeal Flexible King LAD· Patient Size: 30-50kg " Product Usage: Laryngeal airway REF: LAD-903, Lot #K120416 Class II The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO sterilization cycle. The firms investigation revealed that the complainant claims were confirmed; the firm then performed a 100% inspection of all product supplied by Three Lions Ltd. The firm segregated the affected lots of King LAD devices. King Systems Corp.
Devices KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 4 / Adult ClearSeal Flexible King LAD· Patient Size: 50-70kg " Product Usage: Laryngeal airway REF: LAD-904, Lot #K120417 Class II The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO sterilization cycle. The firms investigation revealed that the complainant claims were confirmed; the firm then performed a 100% inspection of all product supplied by Three Lions Ltd. The firm segregated the affected lots of King LAD devices. King Systems Corp.
Devices Superstat Modified Collagen Hemostatic Sponge.115mmx115mm Pledget, 1.5%, Part#9500-15. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques Lot#P0616P, SSK15P Class II The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge. Superstat Corp
Devices Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 1.5%, Part# 9200-15. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques Lot#R0117D, SSK03D. Class II The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge. Superstat Corp
Devices Superstat Modified Collagen Hemostatic Sponge, 115mm x 115mm Pledget, 3.0%, Part# 9500-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques Lot#R0315P, R0316P, R0317P, R1026P, S0703P, S1503P, SSK01P, SSM01P, SSN01P, SSN08P, SSN10P, SSN11P. Class II The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge. Superstat Corp
Devices Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques Lot# R1018D, SSM02D, SSN12D . Class II The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge. Superstat Corp
Devices Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 3.0%, Part# 9300-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques Lot# R1018P, S1503P, S2802P, SSN03P . Class II The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge. Superstat Corp
Devices Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 1.5%, Part# 9105-00. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques Lot# SSC02, SSF02 . Class II The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge. Superstat Corp
Devices Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 3.0%, Part# 9106-00. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques Lot# SSF02, SSF03. Class II The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge. Superstat Corp
Devices Superstat Modified Collagen Hemostatic Sponge, 4x4 Pledget, 3.0%, Part# 9102-00. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques Lot# SSG29, SSG47, SSG52, SSG54, SSG57, SSG60, SSG63, SSG65, SSG66. Class II The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge. Superstat Corp
Devices Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 1.5%, Part# 9120-15, 9100-15. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques Lot# SSK02D, SSK05D. Class II The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge. Superstat Corp
Devices Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 1.5%, Part# 9300-15. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques Lot# SSK07P. Class II The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge. Superstat Corp
Devices Superstat Modified Collagen Hemostatic Sponge, 7.5mm x 19mm Cone, 3.0%, Part# 9015-30, 9003-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques Lot# SSL01C, SSN04C. Class II The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge. Superstat Corp
Devices Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 3.0%, Part# 9100-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques Lot# SSN02D. Class II The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge. Superstat Corp
Devices Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques Lot# SSN12D. Class II The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge. Superstat Corp
Food Tub labeled as Kay's Classic Vanilla Bean ice Cream. UPC 87848-13021, 1.5 Quarts (1.42L). Lid labeled as Kay's Classic Toasted Butter Pecan ice cream Best if Used By 02/28/14 Class II Packaging error. Toasted Butter Pecan ice cream was packaged in a container labeled as Vanilla Bean. However the lid on the package did state Toasted Butter Pecan. Schoep's Ice Cream Co, Inc
Devices INTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments Part number 304534-7500-000; lot number 540958. Class II A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve. Carl Zeiss Meditec, Inc.
Devices INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments. Part number 304534-7500-001; lot number 540959. Class II A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve. Carl Zeiss Meditec, Inc.
Devices INTRABEAM Balloon Applicator Set; 4.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments. Part number 304534-7500-002; lot number 540960. Class II A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve. Carl Zeiss Meditec, Inc.
Devices GE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose radiographic imaging of the human head and body. part number: 5421698 Class II It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique Accuracy as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54. GE Healthcare, LLC
Devices GE Healthcare Optima XR 220amx Mobile general purpose radiographic imaging of the human head and body. part numbers: 5555000-5, 5555000-6 Class II It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique Accuracy as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54. GE Healthcare, LLC
Devices GE Healthcare Optima 200amx Mobile general purpose radiographic imaging of the human head and body. part numbers: 5555000-3, 5555000-4 Class II It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique Accuracy as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54. GE Healthcare, LLC
Devices GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of the human head and body. part numbers:5555000, 5555000-2 Class II It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique Accuracy as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54. GE Healthcare, LLC
Devices The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000). The RIO is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The RIO is indicated for use in surgical knee and hip procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include: Unicondylar knee replacement (UKA) and/or Patellofemoral knee replacement (PKA) and Total Hip Arthroplasty (THA). ROB S/N GUD S/N CAM S/N ROB036 GUD054 CAM054 ROB037 GUD043 CAM037 ROB038 GUD038 CAM038 ROB039 GUD039 CAM039 ROB040 GUD040 CAM035 ROB042 GUD042 CAM043 ROB046 GUD046 CAM046 ROB047 GUD044 CAM047 ROB048 GUD047 CAM048 ROB049 GUD048 CAM049 ROB051 GUD074 CAM074 ROB053 GUD053 CAM053 ROB054 GUD091 CAM091 ROB055 GUD055 CAM075 ROB056 GUD056 CAM066 ROB057 GUD058 CAM058 ROB059 GUD059 CAM059 ROB060 GUD060 CAM060 ROB061 GUD061 CAM061 ROB062 GUD063 CAM062 ROB063 GUD062 CAM063 ROB065 GUD065 CAM033 ROB066  ...
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Class II MAKO Surgical Group recalled their RIO System software, version 2.4 and is implementing software version 2.5 to address a software functional issue with the existing version of the system's software. Loss of tactile feedback constraining the cutting burr has been reported. Mako Surgical Corporation
Food Grape Tomatoes, 199 cartons x 12 packages x 1 pint. Lot#1201015031 Class I Ed Produce is recalling grape tomatoes because they may be contaminated with Salmonella. E.D. Produce
Devices Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic, full-hemisphere, acetabular shell component. Intended Use: The shell utilizes a modular polyethylene liner and a femoral head component that is taper fit onto a femoral stem at the time of surgery. Cemented or non-cemented total hip replacement . The device is intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery at high risk of hip dislocation due to a history of prior dislocation, joint or bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered Part 11-106054 Lot 528310 Class II The color code on label conflicts with the liner size (liner size 24 should be green, not yellow) Biomet, Inc.
Devices Product is Full OSSEOTITE 2 Tapered Certain Implant, Model Number XIFNT413, and size 4 x 13 mm. The product is sterile. Product provides a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures. Model Number XIFNT413, Lot # 2012040462 Class II Biomet 3i recalled Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Certain Implant due to a manufacturing condition where the depth of the implant's internal hex is too shallow. This condition may prevent the driver or abutment from fully engaging in the implant. Biomet 3i, LLC
Devices Product is Full OSSEOTITE Parallel Walled Certain Implant, Model Number IFOA411. The product is sterile. Product provides a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures. Model Number IFOA411, Lot # 2011111333, 2011111333-S1 Class II Biomet 3i recalled Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Certain Implant due to a manufacturing condition where the depth of the implant's internal hex is too shallow. This condition may prevent the driver or abutment from fully engaging in the implant. Biomet 3i, LLC
Drugs Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257 USA; by: Ranbaxy Laboratories Ltd., New Delhi -110 019, India; NDC 63304-827-90 Lot #: 2407258, Exp 05/14 Class II Adulterated Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg. Ranbaxy Inc.
Devices PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube JC470075 Class II One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene vinyl acetate copolymer. Gyrus Acmi, Incorporated
Devices SenTec V-Sign Membrane Changer (VS-MC), 9 pieces. The SenTec V-Sign Membrane Changer is indicated for use with the V-Sign Sensor only. The V-sign Sensor is indicated for use with the SenTec Digital Monitor when continuous non-invasive monitoring of carbon dioxide tension, oxygen saturation, and pulse rate are required for adult and pediatric patients. Lot numbers: 1CF5, 1D21, 1D60, 1DC6, 1DED, 1E0D Class II A manufacturing defect was observed for the membrane changer insert that does not allow electrolyte to be present under the new membrane. The PCO2 performance of a sensor without electrolyte will be deteriorated. Sentec AG
Devices SenTec V-Sign Membrane Changer Insert (VS-MCI), 5 pieces. The SenTec V-Sign Membrane Changer Insert is indicated for use with the V-Sign Membrane Changer only. The V-sign Sensor is indicated for use with the SenTec Digital Monitor when continuous non-invasive monitoring of carbon dioxide tension, oxygen saturation, and pulse rate are required for adult and pediatric patients. Lot numbers: 1D0F, 1D58, 1D80, 1DCA, 1DEA, 1E5F Class II A manufacturing defect was observed for the membrane changer insert that does not allow electrolyte to be present under the new membrane. The PCO2 performance of a sensor without electrolyte will be deteriorated. Sentec AG
Devices CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system. The CapLOX II Spinal System is a posterior, non-cervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion. Model # 2201-5004, Lot # 06110093 Devices are also seialized as 101-110. Class II Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking Captiva Spine, Inc
Food Beagle Bay Organics Brand Raw Sauerkraut, Kimchi Net. Wt. 16 oz (416g). Product is stored/distributed under refrigeration and is intended to be eaten raw as a condiment. Beagle Bay Organics, 4501 Manatee Ave W # 105, Bradenton, FL 34209 Lot # 1210871 Class II Cracker Industries, LLC dba Beagle Bay Organics recalled their Raw Sauerkraut, Kimchi due to a bolt that was found missing from the rotation mixer. Cracker Industries, LLC
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