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FDA MEDWATCH ALERTS

November 21, 2014

FDA MedWatch - Respironics California, Esprit V1000 and V200 Ventilators: Class I Recall - Power Failure May Occur

Summary:

FDA MedWatch Respironics California Esprit V1000 and V200 Ventilators Class I Recall

November 07, 2014

FDA MedWatch - Nellcor Puritan Bennett, 980 Ventilator System: Class I Recall - Software Issue May Stop Ventilator

Summary:

FDA MedWatch Nellcor Puritan Bennett 980 Ventilator System Class I Recall

October 25, 2014

FDA MedWatch - Intravia Containers by Baxter: Recall - Particulate Matter

Summary:

FDA MedWatch Intravia Containers by Baxter Recall

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Self-Education and Evaluation (SEE) Program

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Cook Inc., Central Venous Catheter Trays

Thursday, March 03, 2011

Cook Inc., Single, Double, Triple and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripheral Inserted Central Venous Catheter Trays: Class I Recall - Leaks in Plunger Luer Detected

ISSUE: FDA notified health care professionals of leaks in the plunger luer detected during a routine syringe leak test. The potential exists for leakage and possible loss of sterility. This may lead to serious adverse health consequences and/or death. These products were manufactured from December 4, 2008 through May 1, 2009 and distributed from January 1, 2009 through September 30, 2010.

BACKGROUND: These catheters are used by physicians to monitor a patient’s pressure in a vein, for blood sampling and administration of drugs and fluids.

RECOMMENDATION: Customers were asked to examine their inventory and notify Cook about returning the recalled products.


[03/03/2011 - Recall Notice1 - FDA]

    

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