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Depuy Orthopaedics, Inc.: ProVision Hytrel Universal Hood/Gown; product 5431-31-000

Lack of assurance of sterility, due to the possibility of an incomplete package seal.

FDAJun 27, 2003Nationwide• Depuy Orthopaedics, Inc.

Philips Medical Systems: Easy Access Software releases 1.1, 5.2, 6.2 & 7.2

If DICOM fields for body part, description or accession number are changed, change won't update on the EasyWeb client or hospital systems.

FDAJun 27, 2003Nationwide• Philips Medical Systems

Depuy Orthopaedics, Inc.: ProVision Barrier Universal Hood/Gown; product 5431-33-000

Lack of assurance of sterility, due to the possibility of an incomplete package seal.

FDAJun 27, 2003Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: ProVision Disposable Hood; product 5431-50-000

Lack of assurance of sterility, due to the possibility of an incomplete package seal.

FDAJun 27, 2003Nationwide• Depuy Orthopaedics, Inc.

Henry Schein, Inc.: Positive Touch (TM) TEXTURED POWDER-FREE LATEX EXAM GLOVE...

FDA's analysis revealed defects (holes) in the latex gloves.

FDAJun 27, 2003CT, IN, ME +7 more• Henry Schein, Inc.

Henry Schein, Inc.: Positive Touch (TM) SMOOTH POWDER-FREE LATEX EXAM GLOVES,...

FDA's analysis revealed defects (holes) in the latex gloves.

FDAJun 27, 2003CT, IN, ME +7 more• Henry Schein, Inc.

PerkinElmer Life Sciences Inc: Neonatal GALT Test Kit, 4800 assays per kit, packaged und...

The kits are producing lower values than expected, which may result in an increase of false positive test results.

FDAJun 27, 2003AL, AZ, CO +7 more• PerkinElmer Life Sciences Inc

Cardinal Health: Catalog SBA35GSMOG, Sterile General Surgery Pack, Mfg dat...

The kits labeled as sterile were stolen in transit to the sterilizer and have not been sterilized.

FDAJun 27, 2003MN, MO, NJ +1 more• Cardinal Health

Cardinal Health: Catalog SBA61MJSFH, Sterile Laparotomy Pack, Mfg date 5/2...

The kits labeled as sterile were stolen in transit to the sterilizer and have not been sterilized.

FDAJun 27, 2003MN, MO, NJ +1 more• Cardinal Health

Roche Diagnostics Corp.: MagNA Pure LC Instrument; Catalog number 2236931.

A software bug in version 3.0 may result in prolonged mixing time, evaporation of elution volume and biased sample results for various protocols.

FDAJun 26, 2003Nationwide• Roche Diagnostics Corp.

Boston Scientific Corporation: Wallstent Enteral Endoprothesis with Unistep Plus Deliver...

Mislabeled: Product is labeled as a 20 mm X 90 mm, but is actually a 22 mm X 60 mm

FDAJun 26, 2003CO, FL, IL +4 more• Boston Scientific Corporation

Numed Inc: CP STENT (Cheatham Platinum), a prescription device, comp...

Lacks a PMA or 510k.

FDAJun 26, 2003IN• Numed Inc

Cosco Arriva Infant Car Seats (Dorel) – Child Safety Concern (2003)

The recalled car seats/carriers were sold under the Cosco Arriva and Turnabout brand names and were manufactured by Dorel Juvenile Group in the U.S. The car seat/carriers have the following model numbers: ARRIVA 02-665 02-727 02-728 02-729 02-731 02-732 02-733 02-750 02-751 02-755 02-757 02-774 TURNABOUT 02-753 02-756 02-758 02-759 02-760 02-761 02-762 02-763 02-764 02-765 02-770 02-771 02-772 The model number and manufacture date are located on the instruction and warning label on the side of the car seat/carrier. The recalled seats were manufactured on or before Jan. 31, 2000.

CPSCJun 25, 2003Nationwide• Dorel Juvenile Group Inc., of Columbus, Ind.

Hardy Media Inc Dba Hardy Diag: Blood Agar Plates, 5%, Lot 3155A.

Customers complained of bacterial contamination of lot A10-3155A.

FDAJun 25, 2003Nationwide• Hardy Media Inc Dba Hardy Diag

Coopervision Inc: SOFT CONTACT LENSES (toric) packaged under the following ...

The actual sphere power of the lens is lower than the labeled value.

FDAJun 25, 2003Nationwide• Coopervision Inc

Datascope Corp: Anestar Anesthesia Delivery System

Failure of the Anestar AC Main Power Switch. Battery should last 30 minutes, then ventilation and monitoring will fail.

FDAJun 24, 2003Nationwide• Datascope Corp

Ski-Doo Snowmobiles (Bombardier) – Vehicle Safety Issue (2003)

Laceration Risk

The recalled snowmobiles are 2-tone blue or all black. The name of the engine is written on the hood: Rotax 4-TEC V-1000 or Rotax 2-TEC 800 SDI.

CPSCJun 24, 2003Nationwide• Bombardier Motor Corporation of America, of Grant, Fla.

Little Red Chef Food Slicer – Blade Safety Risk (2003)

Laceration Risk

The recalled red plastic food slicer and dicer contains six roller blades at the front and a single slicing blade on the top. The food slicer is stamped "Made in W. Germany" and "Famos Gerate" on the inside of handle and has a four-pointed star. Only food slicers sold without the protective blade cover are included in this recall.

CPSCJun 24, 2003Nationwide

Little Red Chef Food Choppers – Blade Safety Risk (2003)

Laceration Risk

The food chopper is a red plastic hand-held food slicer and dicer, that contains six roller blades at the front and a single slicing blade on the top. It measures approximately 6.5 inches in length, 2.5 inches in width and 2.0 inches in height at its highest point. The food chopper is stamped on the inside of the handle, "Made in W. Germany" and "Famos Gerate", with a four-pointed star. A flexible white plastic cutting mat that has "Little Red Chef" printed in the upper left-hand corner accompanies the food chopper.

CPSCJun 24, 2003Nationwide

Encision, Inc.: EM2 NC AEM Monitor (NON-COM)

Use of NC versions of AEM monitor presents burn hazard when used with single pad and capacitively coupled patient return electrodes.

FDAJun 23, 2003CA, IL, KS +5 more• Encision, Inc.

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