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Showing 20321–20340 of 22584 results

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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 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

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

Dade Behring Inc.: Dade Fibrin(ogen) Degradation Products (FDP) Detection Se...

positive control shows weak agglutination reaction

FDAJun 21, 2005Nationwide• Dade Behring Inc.

Diagnostica Stago, Inc.: STA-R blood coagulation analyzer. Catalog Number 57160.

Concerning the STA-R blood coagulation analyzer, there is a possible failure mode associated with patient samples receiving prolonged exposure time to reagents during the cuvette roll change process.

FDAJun 20, 2005Nationwide• Diagnostica Stago, Inc.

Beckman Coulter Inc: Beckman Coulter 1500 Series Hematology Automation System;...

Risk of injury to workers due to mechanical or electrical hazards.

FDAJun 20, 2005Nationwide• Beckman Coulter Inc

Beckman Coulter Inc: DL 2000 Data Manager

Version v6.4.109f, any result designated as 'calculated chemistry' at DL2000 may upload to the LIS with an incorrect or blank sample ID.

FDAJun 20, 2005Nationwide• Beckman Coulter Inc

Warsaw Orthopedic, Inc.: Medtronic Sofamor Danek brand METRx System 16 mm Med Proc...

The package is labeled as sterile, but there may be a hole in the immediate package caused by the carton design.

FDAJun 20, 2005Nationwide• Warsaw Orthopedic, Inc.

Abbott Laboratories: 10 French Ross Flexiflo Lap J Laproscopic Jejunostomy Kit...

The kits contain a 12 Fr. Introducer Tear-Away BNS component . The manufacturer of the component B. Braun Medical Inc., Allentown, PA notified Abbott Laboratories by letter dated 5/27/05, that the tearaway introducer sheaths may have cracked hubs/handles and/or improper peeling of the sheath during use in a small percentage of the affected lots.

FDAJun 18, 2005Nationwide• Abbott Laboratories

Medtronic Emergency Response Systems, Inc.: LIFEPAK 20 defbrillator/monitor

The defibrillator may not operate if the device is turned on during an AC Loss Alert.

FDAJun 17, 2005Nationwide• Medtronic Emergency Response Systems, Inc.

Radiometer America Inc: D711, Reference Membranes, Part #942-058, used with the A...

The recalled membranes cause the status value of the pH and electrolyte electrodes to be offset causing readings outside of the acceptable range.

FDAJun 17, 2005Nationwide• Radiometer America Inc

Radiometer America Inc: Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, AB...

Software defect. pO2 and pCO2 sample test results run on the firm's ABL700/800 Series Blood Gas Analyzers are not being properly flagged during the sample calibration phase.

FDAJun 17, 2005Nationwide• Radiometer America Inc

Guidant Corporation: CONTAK RENEWAL 2 (model H155) Heart Failure Device. Steri...

Laboratory analysis revealed that a deterioration in a wire insulator within the lead connector block, in conjunction with other factors, could cause a short circuit and loss of device function due to diversion of therapy energy away from the heart and into device circuitry.

FDAJun 17, 2005Nationwide• Guidant Corporation

Boston Scientific CRM Corp: VENTAK PRIZM AVT model no. 1900, Atrial and Ventricular T...

The atrial therapy (AVT) subgroups of certain Guidant ICD and CRT-D product families are subject to a condition in which a random memory error causes functional 'latching' that limits available therapy.

FDAJun 17, 2005Nationwide• Boston Scientific CRM Corp

Boston Scientific CRM Corp: CONTACT RENEWAL 3 AVT model numbers M150 and M155; CONT...

The atrial therapy (AVT) subgroups of certain Guidant ICD and CRT-D product families are subject to a condition in which a random memory error causes functional 'latching' that limits available therapy.

FDAJun 17, 2005Nationwide• Boston Scientific CRM Corp

Boston Scientific CRM Corp: VITALITY AVT, model A135 and model A155. Implantable Car...

The atrial therapy (AVT) subgroups of certain Guidant ICD and CRT-D product families are subject to a condition in which a random memory error causes functional 'latching' that limits available therapy.

FDAJun 17, 2005Nationwide• Boston Scientific CRM Corp

Guidant Corporation: Ventak PRIZM 2 DR, model 1861 Automatic Implantable Cardi...

Laboratory analysis of returned devices revealed that deterioration in a wire insulator within the lead connector block, in conjuction with other factors, resulted in an electrical short. The short caused diversion of shock therapy energy away from the heart and into device circuitry.

FDAJun 17, 2005Nationwide• Guidant Corporation

Guidant Corporation: CONTAK RENEWAL (model H135) Heart Failure Device Cardiac ...

Laboratory analysis revealed that a deterioration in a wire insulator within the lead connector block, in conjunction with other factors, could cause a short circuit and loss of device function due to diversion of therapy energy away from the heart and into device circuitry.

FDAJun 17, 2005Nationwide• Guidant Corporation

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