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Showing 66201–66220 of 68218 results

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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: 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

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

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: 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

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

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.

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

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.: 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.

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

Namsa: Self Contained Biological Indicator, product code SCRE-06...

The certified Ethylene Oxide D-values of the lots cannot be confirmed to be within specification.

FDAMar 18, 2005CA, NH, NJ +2 more• Namsa

Medline Industries, Inc.: Medline Custom Anesthesia Circuit Adult 40in Mask 3L Kit ...

The procedure packs contain anesthesia/breathing circuits being recalled by MMS Sales due to partial occlusion of the T-piece resulting in airway obstruction.

FDAMar 18, 2005AL, CA, FL +2 more• Medline Industries, 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

Medline Industries, Inc.: Medline Custom Anesthesia Super Circuit Adult 60 Unilimb ...

The procedure packs contain anesthesia/breathing circuits being recalled by MMS Sales due to partial occlusion of the T-piece resulting in airway obstruction.

FDAMar 18, 2005AL, CA, FL +2 more• Medline Industries, Inc.

Medline Industries, Inc.: Medline Custom Anesthesia Set Up Kit - Latex Free (non-st...

The procedure packs contain anesthesia/breathing circuits being recalled by MMS Sales due to partial occlusion of the T-piece resulting in airway obstruction.

FDAMar 18, 2005AL, CA, FL +2 more• Medline Industries, Inc.

Medline Industries, Inc.: Medline Custom Open Heart CDS Kit (non-sterile), reorder ...

The procedure packs contain anesthesia/breathing circuits being recalled by MMS Sales due to partial occlusion of the T-piece resulting in airway obstruction.

FDAMar 18, 2005AL, CA, FL +2 more• Medline Industries, Inc.

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