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Cook Inc., Single, Double, Triple and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripheral Inser

Posted Mar 03 2011 5:10pm

[Posted 03/03/2011]

AUDIENCE: Risk Manager

ISSUE: FDA notified healthcare 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 Notice - FDA]

    
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