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Medtronic, Inc.: CATH. GUIDE 7F SR3.5 LAUNCHER CATHETER LA7SR35 LA 7F 100C...

Potential for non-sterility due to loss of package integrity

FDAApr 5, 2006Nationwide• Medtronic, Inc.

Medtronic, Inc.: 6F ZUMA SR5.0 Coronary Guiding catheter designed to prov...

Potential for non-sterility due to loss of package integrity

FDAApr 5, 2006Nationwide• Medtronic, Inc.

EP Medsystems: EP-4 Computerized Stimulator -- 2 channel and 4 channel. ...

Under certain circumstances the device may exhibit the following behaviors: 1)-Initiation of a rapid stimulation train without command, when the device is in use in conjuction with an electrosurgical unit or RF ablation unit-2)-Presence of a DC offset voltage on an output channel-3)-Inability to synchronize with a non-EP MedSystems recording system

FDAApr 4, 2006Nationwide• EP Medsystems

InFocus LP120 Projector (InFocus) – Shock Risk (2006)

This recall involves portable projectors designed for use with laptop computers, and a replacement lamp module sold for use with these projectors. The recalled projector models are InFocus LP120 and ASK Proxima M1, built between October 2005 and January 2006. The model number and serial numbers are written on the bottom of the projectors. They have the following serial numbers: Model LP120 - AJNV541A0001 through AJNV551A0301 Model M1 - AKUV546A0001 through AKUV547A0268 The recalled replacement lamp module is SP-LAMP-013, built between November 2005 and January 2006. There is no writing on the lamps, but "SP-LAMP-013" is on the label on the box.

CPSCApr 4, 2006Nationwide

Massaging Bed Rest (Brookstone) – Burn Hazard (2006)

The recalled bed rest is designed to support a person sitting in bed. It is beige and consists of a back, two foldable armrests with a cup holder and massage controls, and a headrest with a reading light attached. "Imported by Brookstone Company" is printed on a tag attached to the bed rest. The massaging bed rest also provides heat at a single setting. A curly beige cord is attached to the back lower left corner of the bed rest. On some of the bed rests, "SKU NO: 431254" is printed on a round metal plate where the curly beige cord plugs into the bed rest. "Brookstone" is printed on the beige plug-in transformer that attaches to the beige cord.

CPSCApr 4, 2006Nationwide• Brookstone Company Inc., of Merrimack, N.H.

Tecumseh Engines (Tecumseh Power Co.) – Fire Hazard (2006)

The recall includes power equipment with Tecumseh engines listed below. The engine model number and date of manufacture (DOM) information is located on a label on the side of the housing. The recalled engines have a date of manufacture code (DOM) that starts with 05241 to 05286. The label on the engine reads, "Tecumseh Power Company," and in addition to the Model and DOM information, lists the Spec number needed for identification. Power Equipment Brand Names Two-Stage Snow Throwers Ariens, Craftsman, Cub Cadet, Huskee, Husqvarna, MTD Gold Series, Murray, Toro, Poulan Pro,Troy-Bilt, White Outdoor, Yard Machines, Yard Man Log Splitters Yard Machines Ice Augers and Post Hole Diggers Jiffy, Eskimo, Earthquake, Hoffco, MEPCO Fun-Karts Carter Brothers, Ken Bar Generators Coleman Powermate, NorthStar Lawn Vac/Chipper Agri-Fab, Craftsman Lawn Mower Toro String Trimmers Ariens

CPSCApr 4, 2006Nationwide• Tecumseh Power Co., Grafton, Wis.

Roche Diagnostics Corp.: Roche MagNA Pure LC Total Nucleic Acid Isolation Kit - La...

The firm has received complaints of reagent splattering on the deck of the instrument and possible cross contamination of samples purified on the instrument.

FDAApr 4, 2006Nationwide• Roche Diagnostics Corp.

Medtronic Neurological: Medtronic Kinetra 7428. Dual Program Neurostimulator fo...

A specific subset of model 7428 Kinetra implantable neurostimulators may fail due to lifted wirebonds between the hybrid circuit and battery. This failure mechanism may present clinically as loss of functionality and a return of the patient's underlying medical conditions.

FDAApr 4, 2006CA, OR, PA• Medtronic Neurological

Roche Diagnostics Corp.: Roche MagNA Pure LC System. An automated, general purpos...

The firm has received complaints of reagent splattering on the deck of the instrument and possible cross contamination of samples purified on the instrument.

FDAApr 4, 2006Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche MagNA Pure LC DNA Isolation Kit - Large Volume; Cat...

The firm has received complaints of reagent splattering on the deck of the instrument and possible cross contamination of samples purified on the instrument.

FDAApr 4, 2006Nationwide• Roche Diagnostics Corp.

Siemens Healthcare Diagnostics: RapidLab 1200 Systems, Model 1245 - Blood gases, electrol...

Invalid CO-oximeter values; Bayer HealthCare determined that under very specific conditions, the RapidLab 1245 or RapidLab 1265 systems may report invalid CO-oximeter values to an LIS, Rapidlink, or Rapidcomm data management system.

FDAApr 4, 2006Nationwide• Siemens Healthcare Diagnostics

Ski-Doo Snowmobiles (BRP) – Projectile Risk (2006)

The recall involves all models and packages of the Model Years 2005 and 2006 Mach Z and all models and packages of the Model Year 2006 MX Z Renegade 1000 Ski-Doo® snowmobiles. The Mach Z model was available in black and the MXZ model was available in black or yellow. Model name is located on the side panels.

CPSCApr 3, 2006Nationwide• Bombardier Recreational Products Inc. (BRP), of Quebec, Canada

Dade Behring Inc.: Stratus CS STAT Fluorometric Analyzer BHCG TestPak (CBHCG...

Foil sealing of theTestPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or depressed, and the magnitude of the inaccuracy may vary based on the degree of occlusion.

FDAApr 3, 2006Nationwide• Dade Behring Inc.

EM Innovations Inc: Model EMI 82691, Stic Kit Needle Containment Device. The...

The firm failed to include User Instructions with the Stic Kit Needle Containment Device, Model EMI 82691, which they shipped to distributor/customers.

FDAApr 3, 2006IN, MO, NJ +3 more• EM Innovations Inc

Disetronic Medical Systems, Inc.: Disetronic Ultraflex 8/80 infusion set; Catalog number 44...

The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia

FDAMar 31, 2006Nationwide• Disetronic Medical Systems, Inc.

Disetronic Medical Systems, Inc.: Accu-Chek Ultraflex-2 infusion set; 8 mm 24'' (60 cm); Ca...

The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia

FDAMar 31, 2006Nationwide• Disetronic Medical Systems, Inc.

Disetronic Medical Systems, Inc.: Accu-Chek Ultraflex-8 infusion set; Catalog number 454477...

The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia

FDAMar 31, 2006Nationwide• Disetronic Medical Systems, Inc.

Disetronic Medical Systems, Inc.: Accu-Chek Ultraflex soft DUS 1 infusion set; 8 mm (60 cm)...

The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia

FDAMar 31, 2006Nationwide• Disetronic Medical Systems, Inc.

Magnetix Magnetic Building Sets – Child Safety (2006)

All Magnetix magnetic building sets, including the X-treme Combo, Micro, and Extreme sets. The sets contain 20 to 200 plastic building pieces and 20 to 100 1/2-inch diameter steel balls. The building pieces are red, yellow, blue and green, and are shaped in 1 1/2-inch squares, 1-inch triangles and cylinder rods. Some plastic building pieces have "Magnetix" imprinted on them.

CPSCMar 31, 2006Nationwide

Disetronic Medical Systems, Inc.: Accu-Chek Ultraflex 1-infusion set; 8 mm 24'' (60 cm); Ca...

The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia

FDAMar 31, 2006Nationwide• Disetronic Medical Systems, Inc.

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