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Showing 65941–65960 of 68218 results

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Medtronic Powered Surgical Solutions: Medtronic MIDAS REX Legend High Speed Pneumatic System, G...

Complaints of finger control component breaking off and falling into open surgical wound.

FDAJun 29, 2005Nationwide• Medtronic Powered Surgical Solutions

Vygon Corporation: Premicath 28G PICC Catheter

Guidewire protuding from tip of the catheter

FDAJun 27, 2005CA, CO, FL +9 more• Vygon Corporation

Boston Scientific Corporation: Hemashield Vantage Vascular Graft. Vascular graft prosth...

During surgery, several reports of the grafts fraying and tearing upon suturing by the surgeon.

FDAJun 27, 2005IN• Boston Scientific Corporation

Argon Medical Devices, Inc: Product consists of a syringe used to inject fluids durin...

The firm is recalling the product due to the potential for air aspiration or fluid leakage from a faulty syringe tip.

FDAJun 27, 2005CA, IL, IN +6 more• Argon Medical Devices, Inc

Abbott Laboratories MPG: XSYSTEMS AxSYM Multiconstituent Controls for Abused Drug ...

The XSYSTEMS Multiconstituent Controls accessory insert (commodity number 34-3067/R6) does not contain the correct control ranges for the AxSYM Opiates assay.

FDAJun 27, 2005Nationwide• Abbott Laboratories MPG

Natus Medical Inc: Natus Algo Pre-Amplifier 3 cable assembly (Component of t...

Internal investigation revealed that Preamp cable assemblies in the device had not been properly tested, which could lead to potential shock to users.

FDAJun 27, 2005IN• Natus Medical Inc

Argon Medical Devices, Inc: Labeling is as follows: Product Labeling: ''***Argon Me...

The firm is recalling the product due to the potential for air aspiration or fluid leakage from a faulty syringe tip.

FDAJun 27, 2005CA, IL, IN +6 more• Argon Medical Devices, Inc

Guidant Corporation: CONTAK RENEWAL 4 AVT CRT-D (model no. M170 and M175) and ...

Engineering analysis has determined that the magnetic switch in certain devices may stick in the closed position. When the magnetic switch becomes stuck in the closed position treatment of ventricular or atrial tachyarrhythmias is inhibited, while bradycardia pacing is unaffected.

FDAJun 24, 2005Nationwide• Guidant Corporation

Guidant Corporation: CONTAK RENEWAL 4 CRT-D (model no. H190 and H195) and CONT...

Engineering analysis has determined that the magnetic switch in certain devices may stick in the closed position. When the magnetic switch becomes stuck in the closed position treatment of ventricular or atrial tachyarrhythmias is inhibited, while bradycardia pacing is unaffected.

FDAJun 24, 2005Nationwide• Guidant Corporation

Guidant Corporation: CONTAK RENEWAL 3 AVT CRT-D (model no. M150 and M155) and ...

Engineering analysis has determined that the magnetic switch in certain devices may stick in the closed position. When the magnetic switch becomes stuck in the closed position treatment of ventricular or atrial tachyarrhythmias is inhibited, while bradycardia pacing is unaffected.

FDAJun 24, 2005Nationwide• Guidant Corporation

Guidant Corporation: CONTAK RENEWAL 4 RF (model no. H230 and H235) and CONTAK ...

Engineering analysis has determined that the magnetic switch in certain devices may stick in the closed position. When the magnetic switch becomes stuck in the closed position treatment of ventricular or atrial tachyarrhythmias is inhibited, while bradycardia pacing is unaffected.

FDAJun 24, 2005Nationwide• Guidant Corporation

Unknown Manufacturer: EBI Trochanteric 11mm Long Nail.

Upon evaluation, the firm found that the fatigue strength of these nails was below the required value as specified in the design specification.

FDAJun 24, 2005Nationwide

Guidant Corporation: CONTAK RENEWAL 3 CRT-D (model no. H170, H173, H175) and C...

Engineering analysis has determined that the magnetic switch in certain devices may stick in the closed position. When the magnetic switch becomes stuck in the closed position treatment of ventricular or atrial tachyarrhythmias is inhibited, while bradycardia pacing is unaffected.

FDAJun 24, 2005Nationwide• Guidant Corporation

Cobe Cardiovascular, Inc: ASY Brat 2 Procedure Set, for blood recovery & autotrans...

Packaging trays may have holes in them as a result of the sealing process, which could compromise the sterility of the product.

FDAJun 22, 2005Nationwide• Cobe Cardiovascular, Inc

Cobe Cardiovascular, Inc: ASY, Brat Pack Procedure Set

Packaging trays may have holes in them as a result of the sealing process, which could compromise the sterility of the product.

FDAJun 22, 2005Nationwide• Cobe Cardiovascular, Inc

Core Brands: Healing Labs Rite Choice Pregnancy Test Kit, packed in a ...

Home pregnancy test kit lacks 510k approval and cannot be assured as safe and effective.

FDAJun 22, 2005IN, MD, MA +5 more• Core Brands

Cobe Cardiovascular, Inc: ASY Brat 2 Procedure Set

Packaging trays may have holes in them as a result of the sealing process, which could compromise the sterility of the product.

FDAJun 22, 2005Nationwide• Cobe Cardiovascular, Inc

Cobe Cardiovascular, Inc: ASY, Brat 2 Pack Procedure Set

Packaging trays may have holes in them as a result of the sealing process, which could compromise the sterility of the product.

FDAJun 22, 2005Nationwide• Cobe Cardiovascular, Inc

Baxter Healthcare Renal Div: HomeChoice PRO Automated Peritoneal Dialysis Systems; Man...

The screws that secure the Power Entry Module (PEM) to the base of the HomeChoice device are not reliably grounded to the device's ground system, posing an elcetric shock hazard.

FDAJun 21, 2005Nationwide• Baxter Healthcare Renal Div

Baxter Healthcare Renal Div: HomeChoice Automated Peritoneal Dialysis Systems; Manufac...

The screws that secure the Power Entry Module (PEM) to the base of the HomeChoice device are not reliably grounded to the device's ground system, posing an electric shock hazard.

FDAJun 21, 2005Nationwide• Baxter Healthcare Renal Div

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