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Showing 62421–62440 of 68218 results

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Unknown Manufacturer: ev3 IntraCoil Self-Expanding Peripheral Stent, Sterile E...

Incorrect Label - an IntraCoil 5mm x 40 mm stent was labeled as a 5 mm x 60 mm stent (VT-5-40-135 was labeled as VT-5-60-135).

FDAApr 2, 2008Nationwide

Stryker Communications Corp: OPHIT Optical Digital Visual Interface (DVI) Extender, P...

Product at times experiences intermittent signal loss due to electromagnetic interference.

FDAApr 1, 2008Nationwide• Stryker Communications Corp

Arrow International Inc: Arrow Balloon Temporary Pacing Catheter Kits, Part number...

The 5 Fr. (110cm) Temporary Pacing Catheter/ 6 Fr. Introducer Kits do not contain a complete 6 Fr. Introducer Assembly.

FDAApr 1, 2008Nationwide• Arrow International Inc

EKOS Corporation: Infusion System. EKOS EndoWave Infusion System. EKOS Endo...

Catheter disconnection. There is a potential for the catheter to disconnect from the Catheter Interface Cable (CIC) pod which connects to the Control Unit.

FDAApr 1, 2008Nationwide• EKOS Corporation

GE Healthcare: GE Voluson E8 Ultrasound System with software versions 6....

Inaccurate dimension measurements in M-Mode when pan-Zoom is activated in GE Voluson E8 Ultrasound Systems. Of particular concern are potential inaccuracies of fetal cardiac measurements that may impact patient safety.

FDAApr 1, 2008AL, AZ, AR +45 more• GE Healthcare

Smith And Nephew, Inc. Wound Management Division: FLAT DRAIN -10MM, CHARIKER-JETER DRESSING KITS (LARGE AND...

Incorrect labeling. Kit labels may incorrectly state that a flat drain is contained as a kit component while some kits may contain a round drain.

FDAMar 31, 2008Nationwide• Smith And Nephew, Inc. Wound Management Division

Computerized Medical Systems Inc: Focal Radiation Treatment Planning System, Focal Release...

Focal: In absolute dose mode a beam with a port may be calculated with open normalization, with the result that the displayed dose reflects open normalization while the monitor units and QA plan reflect blocked normalization. This is particularly important when these beams also include compensators. The problem is detectable by looking at the delivered dose to the weight point in the patient as

FDAMar 31, 2008Nationwide• Computerized Medical Systems Inc

Medline Industries Inc: Bariatric Wheelchair, 28" Wide and 20" Deep Seat, 700 lb....

Injuries to fingers. There is a potential for users to pinch their fingers between the seat bars when opening the wheelchairs. The injuries can be severe from fracture to severing.

FDAMar 31, 2008Nationwide• Medline Industries Inc

Medline Industries Inc: Bariatric Wheelchair, 26" Wide and 20" Deep Seat, 700 lb....

Injuries to fingers. There is a potential for users to pinch their fingers between the seat bars when opening the wheelchairs. The injuries can be severe from fracture to severing.

FDAMar 31, 2008Nationwide• Medline Industries Inc

Medline Industries Inc: Bariatric Wheelchair, 24" Wide and 19" Deep Seat, 600 lb....

Fingers can get injured. There is a potential for users to pinch their fingers between the seat bars when opening the wheelchairs. Injuries can be severe from fractures to severing.

FDAMar 31, 2008Nationwide• Medline Industries Inc

Stryker Endoscopy: 24mm Rotating C-Mount Coupler, Model Number 1088-020-121S...

The coupler on this device was manufactured without set-screws that are used to hold and center the rear assembly and the endobody. The coupler is part of the camera system and affects the ability to focus.

FDAMar 31, 2008IN, IA• Stryker Endoscopy

Celsus Laboratories Inc: Celsus Laboratories Heparin Lithium Lyophilized; Lithium ...

Contamination: The firm learned that up to 2.2% oversulfated chondroitin was found in a batch of crude heparin they received from their supplier.

FDAMar 31, 2008IN, NE, NJ +2 more• Celsus Laboratories Inc

GE Healthcare: GE 1.5T and 3.0T Signa HDX MR System Model Number(s): 22...

Possible misdiagnosis or inappropriate treatment based on the image. Signal homogeneity may be affected when BRAVO applications are set with IR Prep off. The concern is that signal inhomogeneity can result in an erroneous diagnosis.

FDAMar 28, 2008AL, AK, AZ +43 more• GE Healthcare

Unknown Manufacturer: Tyco HealthcareMonoject Prefill 10U/mL Heparin Lock Flush...

Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical Ingredient has a heparin-like contaminant

FDAMar 28, 2008Nationwide

Unknown Manufacturer: Tyco Healthcare Monoject Prefill 10U/rnL Heparin Lock Flu...

Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical Ingredient has a heparin-like contaminant.

FDAMar 28, 2008Nationwide

Acumed LLC: Osteo-Clage Cable System Package Assembly (01-0001-S). P...

Cables of incorrect diameter were used in product assembly, resulting in the sleeve not being able to bind to the cable after crimping.

FDAMar 28, 2008Nationwide• Acumed LLC

Baxter Healthcare Corp. Rt.: Logix TPN Software Solution, catalog 2M8410, consists of ...

Software anomaly results in inaccurate information being printed out on the Delivery Report, even though the compounder performed the compounding correctly.

FDAMar 28, 2008AZ, MN, WI +1 more• Baxter Healthcare Corp. Rt.

Unknown Manufacturer: Tyco Healthcare Tyco HealthcareMonoject Prefill 10U/mL He...

Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical Ingredient has a heparin-like contaminant

FDAMar 28, 2008Nationwide

Porex Surgical, Inc.: Ocular Conformer, Sterile, Porex Surgical Inc., 15 Dart R...

The Ocular Conformers were distributed with an expired expiration date.

FDAMar 28, 2008PA• Porex Surgical, Inc.

EMD Chemicals Inc: EMD Chemicals, Harleco Brand Ethanol Standard, 1.0 mg/ml;...

Incorrect concentration: 2 ampules measuring 2.0 mg/ml were found in a lot of 20 ampules of 1.0 mg/ml Ethanol Standard.

FDAMar 27, 2008Nationwide• EMD Chemicals Inc

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