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Showing 20561–20580 of 22584 results

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Roche Diagnostics Corp.: Roche CoaguChek System Controls (patient self testing); C...

Laceration Risk

Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass.

FDAMar 28, 2005Nationwide• Roche Diagnostics Corp.

Baxter Healthcare Corp. Rt.: Baxter Spinal Anesthesia Trays; sterile, single use only ...

The anesthesia trays contain BD 25G Spinal Needles which which have leakage at the plastic hub of the needle.

FDAMar 28, 2005Nationwide• Baxter Healthcare Corp. Rt.

Becton Dickinson Medical Systems: 16 G / 5F Dual Lumen L-Cath Basic Kit with Insyte Autoguard

Aspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters.

FDAMar 25, 2005AL, CA, CO +18 more• Becton Dickinson Medical Systems

Becton Dickinson Medical Systems: 16 G / 5F Dual Lumen L-Cath Complete Kit with Introsyte ...

Aspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters.

FDAMar 25, 2005AL, CA, CO +18 more• Becton Dickinson Medical Systems

Becton Dickinson Medical Systems: 16 G / 5F Dual Lumen L-Cath catheter only.

Aspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters.

FDAMar 25, 2005AL, CA, CO +18 more• Becton Dickinson Medical Systems

Harmony Brands Llc: Lover brand lubricated latex condoms in various presentat...

Lack of assurance of safety and efficacy; products are from unknown sources.

FDAMar 25, 2005Nationwide• Harmony Brands Llc

Medtronic Perfusion Systems: Medtronic Custom Packs and Total System Packs. Pack can...

Some warehouse inventory of Custom Pack product bags were found with ruptured seals. The seals were partially opened in the center of the bag's Tyvek edge. Since this bag is used to enclose and seal the custom pack assembly & had been sterilized, the ruptured seal breaches the sterility barrier for the package.

FDAMar 25, 2005Nationwide• Medtronic Perfusion Systems

Nichols Institute Diagnostics: Nichols IRMA Intact PTH Assay, catalog No. 40-2171

Firm noted a change in performance and therefore changed the labeled performance specifications in the Directional Insert portion of the labeling.

FDAMar 25, 2005Nationwide• Nichols Institute Diagnostics

Harmony Brands Llc: B-Sure brand one step home pregnancy test distributed by ...

Lack of assurance of safety and efficacy; products are from unknown sources.

FDAMar 25, 2005Nationwide• Harmony Brands Llc

Chad Therapeutics Inc: Sequoia Oxymatic electronic oxygen conservers. Models OM-...

"Shot size" below manufacturing specifications. Risk of less than the specified quantity of oxygen delivered per pulse.

FDAMar 25, 2005Nationwide• Chad Therapeutics Inc

Abbott Health Products, Inc.: AxSYM total B-hCG Reagent is composed of one bottle of Co...

Abbott Diagnostics is investigation a recent increase in customer complaints for AxSYM calibration error code 1048 and controls out of range when using AxSYM Total B-hCG reagent lots. Testing has shown that protein aggregates are present in the specimen diluents of both IMx and the AxSYM Total B-hCG reagent kits. This is responsible for the calibration errors and shift in control values.

FDAMar 24, 2005Nationwide• Abbott Health Products, Inc.

Intuitive Surgical, Inc.: 8mm EndoWrist Bipolar Maryland Instrument, Part Number: 4...

The products were incorrectly programmed as training instruments, which allows for 30 uses (surgical procedures) instead of 10 uses.

FDAMar 24, 2005FL, IN, LA +7 more• Intuitive Surgical, Inc.

Abbott Health Products, Inc.: IMx total B-hCG Reagent is composed of one bottle of Coat...

Abbott Diagnostics is investigating a recent increase in customer complaints for IMx calibration error code 157 and controls out of range when using IMx total B-hCG Reagent Lot 25459Q100. Testing has shown that protein aggregates are present in the specimen diluents of both IMx and the AxSYM Total B-hCG reagent kits. This is responsible for the calibration errors and shift in control values.

FDAMar 24, 2005Nationwide• Abbott Health Products, Inc.

Maquet Inc: Servo-i Ventilator

Complaints about batteries indicating a satisfying remaining time but after a short time suddenly shut off without giving alarms to indicate short remaining battery back-up time. (Power off alarm will be given).

FDAMar 24, 2005Nationwide• Maquet Inc

Vygon Neuro: 10 cm Scopable Catheter Reservoir

stylet in package is shorter than that claimed on the label

FDAMar 24, 2005CA, IN• Vygon Neuro

Vygon Neuro: 7 cm Catheter Reservoir with 10 cm extension

stylet in package is shorter than that claimed on the label

FDAMar 24, 2005CA, IN• Vygon Neuro

Vygon Neuro: 6 cm Catheter Reservoir with 10 cm extension

stylet in package is shorter than that claimed on the label

FDAMar 24, 2005CA, IN• Vygon Neuro

Abbott Health Products, Inc. Hwy 2 Km 58.0 Cruze Davila: In vitro Test TDx/TDxFLx Cyclosporine Monoclonal Whole B...

Patient results reported using calibrators made from new primary material may be falsely decreased by 5-8% compared to results using calibrators made from the previous primary material. An Important Product Information Letter with technical information regarding the Whole Blood Calibrators and Controls, implementing new internal reference standards was issued.

FDAMar 23, 2005Nationwide• Abbott Health Products, Inc. Hwy 2 Km 58.0 Cruze Davila

Medrad Inc: Continuum MR Compatible Infusion Pump. Pump Model #3009135

Customer complaint that a continuum infusion pump was attracted to an MR scanner due to customer not completely engaging the pump into the bracket.

FDAMar 22, 2005Nationwide• Medrad Inc

Arrow International Inc: The Arrow Trerotola Percutaneous Thrombolytic Device (Pro...

The orange Pebax lumen located within the catheter basket may separate from the catheter basket sleeve permitting the lumen to become dislodged during use.

FDAMar 18, 2005Nationwide• Arrow International Inc

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