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
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]