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DePuy Orthopaedics, Inc. - ULTIMALX STM - Class 2 Recall
ULTIMA*LX STM,POL 10/12TAP/SZ3 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Source: Medical Device Recalls - June 29, 2012 Category: Medical Equipment Source Type: alerts

DePuy Orthopaedics, Inc. - LUSTER HIP - Class 2 Recall
LUSTER HIP SZ 6 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Source: Medical Device Recalls - June 29, 2012 Category: Medical Equipment Source Type: alerts

DePuy Orthopaedics, Inc. - ULTIMALX STM - Class 2 Recall
ULTIMA*LX STM,POL 10/12TAP/2M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Source: Medical Device Recalls - June 29, 2012 Category: Medical Equipment Source Type: alerts

DePuy Orthopaedics, Inc. - LUSTER HIP - Class 2 Recall
LUSTER HIP SZ 5 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Source: Medical Device Recalls - June 29, 2012 Category: Medical Equipment Source Type: alerts

DePuy Orthopaedics, Inc. - ULTIMALX STM - Class 2 Recall
ULTIMA*LX STM,POL 10/12TAP/SZ5 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Source: Medical Device Recalls - June 29, 2012 Category: Medical Equipment Source Type: alerts

DePuy Orthopaedics, Inc. - LUSTER HIP - Class 2 Recall
LUSTER HIP SZ 10 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Source: Medical Device Recalls - June 29, 2012 Category: Medical Equipment Source Type: alerts

DePuy Orthopaedics, Inc. - ULTIMALX STM - Class 2 Recall
ULTIMA*LX STM,POL 10/12TAP/SZ1 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Source: Medical Device Recalls - June 29, 2012 Category: Medical Equipment Source Type: alerts

DePuy Orthopaedics, Inc. - LUSTER HIP - Class 2 Recall
LUSTER HIP SZ 9 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Source: Medical Device Recalls - June 29, 2012 Category: Medical Equipment Source Type: alerts

DePuy Orthopaedics, Inc. - ULTIMALX STM - Class 2 Recall
ULTIMA*LX STM,POL 10/12TAP/1M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Source: Medical Device Recalls - June 29, 2012 Category: Medical Equipment Source Type: alerts

Polymer Technology Systems, Inc. - PTS Panels Creatinine test strips. - Class 2 Recall
PTS Panels Creatinine test strips. PTS Panels Creatinine Test Strips are intended to measure creatinine in whole blood. Creatinine measurements are used in the diagnosis and treatment of renal (kidney) diseases and in the monitoring of renal dialysis. This system is intended for the professional use for accurately and reproducibly measuring creatinine in human whole blood obtained from a finger stick sample
Source: Medical Device Recalls - June 28, 2012 Category: Medical Equipment Source Type: alerts

Colgate Palmolive Company - Colgate 360 Replaceable Head Battery Powered Toothbrush Medium - Class 2 Recall
Colgate 360 Replaceable Head Battery Powered Toothbrush Medium UPC03500068750 Dist. by Colgate-Palmolive Co. New York, NY 10022 Made in China. For teeth cleansing.
Source: Medical Device Recalls - June 27, 2012 Category: Medical Equipment Source Type: alerts

Zimmer, Inc. - Bigliani/FlatowThe Complete Shoulder Solution Trabecular Metal Glenoid Instr Drill w/Stop - Class 2 Recall
Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm; the products are medical instruments intended for use when performing surgery of the shoulder.
Source: Medical Device Recalls - June 27, 2012 Category: Medical Equipment Source Type: alerts

Colgate Palmolive Company - Colgate 360 Replaceable Head Battery Powered Bonus Twin Pack Toothbrush Soft - Class 2 Recall
Colgate 360 Replaceable Head Battery Powered Bonus Twin Pack Toothbrush Soft UPC 03500068762 Dist. by Colgate-Palmolive Co. New York, NY 10022 Made in China. For teeth cleansing.
Source: Medical Device Recalls - June 27, 2012 Category: Medical Equipment Source Type: alerts

Colgate Palmolive Company - Colgate 360 Replaceable Head Battery Powered Toothbrush Soft - Class 2 Recall
Colgate 360 Replaceable Head Battery Powered Toothbrush Soft UPC 03500068747 Dist. by Colgate-Palmolive Co. New York, NY 10022 Made in China. For teeth cleansing.
Source: Medical Device Recalls - June 27, 2012 Category: Medical Equipment Source Type: alerts

Colgate Palmolive Company - Colgate Adult Motion Whitening Battery Toothbrush - Class 2 Recall
Colgate Adult Motion Whitening Battery Toothbrush UPC 035000691507 Dist. by Colgate-Palmolive Co. New York, NY 10022 Made in China. For teeth cleansing.
Source: Medical Device Recalls - June 27, 2012 Category: Medical Equipment Source Type: alerts

Colgate Palmolive Company - Colgate Adult Motion Battery Toothbrush - Class 2 Recall
Colgate Adult Motion Battery Toothbrush UPC 035000686213 Dist. by Colgate-Palmolive Co. New York, NY 10022 Made in China. For teeth cleansing.
Source: Medical Device Recalls - June 27, 2012 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corporation - Sarns - Class 2 Recall
SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 12-GAUGE BLUE NEEDLE,RECTANGULAR FLANGE AND SUTURE COLLAR, 6" (15CM) LONG Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures.
Source: Medical Device Recalls - June 27, 2012 Category: Medical Equipment Source Type: alerts

Sekisui Diagnostics Llc - MULTIGENT Acetaminophen for use with Architect/Aeroset - Class 2 Recall
MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for the quantitative determination of acetaminophen in human serum or plasma.
Source: Medical Device Recalls - June 27, 2012 Category: Medical Equipment Source Type: alerts

Ethicon, Inc. - Class 2 Recall
Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip Distributed by Ethicon Ethicon Inc., Somerville, NJ 08876 USA Manufactured by Ferrosan Medical Devices Ferrosan Medical Devices A/S Sydmarken 5, DK-2860 Soeberg, Denmark Mixed with sterile saline or thrombin solution is indicated for surgical procedures (except opthalmic) for hemostasis when control of capillary, venous and arteriolar bleeding by pressure, ligature, and other conventional procedures is ineffective or impractical.
Source: Medical Device Recalls - June 27, 2012 Category: Medical Equipment Source Type: alerts

SALTER LABS - Adult Divided Cannula end tidal C)2 sampling w/male luerlock connector - Class 2 Recall
Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 ft, oxygen tube, 7 ft. CO2 tube RX only.For Single Patient Use only. Distributed by Tri-Anium Assembled in Mexico. Usage: Delivery of Anesthesia.
Source: Medical Device Recalls - June 27, 2012 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge - Class 2 Recall
Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge (K6442) B12 Flex Reagent Cartridge used with the Dimension Vista System for the in vitro diagnostic test for the quantitative measurement of Vitamin B12 in human serum and plasma.
Source: Medical Device Recalls - June 27, 2012 Category: Medical Equipment Source Type: alerts

Philips Healthcare Inc. - Philips HeartStart MRx - Class 2 Recall
Philips HeartStart MRx monitor/defibrillators Models: M3535A, M3536A, M3536M4, M3536M5, and M3536M6 Product Usage: The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician
Source: Medical Device Recalls - June 27, 2012 Category: Medical Equipment Source Type: alerts

Medical Components, Inc dba MedComp - MedComp 8F Plastic ProFuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Cathet - Class 2 Recall
MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Catheter. Power Injectable Implantable Infusion Port insertion kit.
Source: Medical Device Recalls - June 26, 2012 Category: Medical Equipment Source Type: alerts

Arrow International Inc - Arrow TwoLumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) Catheter - Class 1 Recall
Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) Catheter Product Usage: The multiple-lumen catheter permits venous access to central circulation.
Source: Medical Device Recalls - June 26, 2012 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - BCS(R) Behring Coagulation System - Class 2 Recall
BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product Usage: Multipurpose system for In Vitro coagulation studies
Source: Medical Device Recalls - June 26, 2012 Category: Medical Equipment Source Type: alerts

Hill-Rom, Inc. - Advanta 2 Bed. - Class 2 Recall
Advanta 2 Bed. The Advanta 2 Bed is intended for low to moderate acuity patients in the medical/surgical area of the hospital.
Source: Medical Device Recalls - June 22, 2012 Category: Medical Equipment Source Type: alerts