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

Share

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.

Read the MedWatch safety alert, including a link to the Class I Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm245634.htm

 

Share
This entry was posted in FDA 2011, FDA Recall and tagged , , , , , , . Bookmark the permalink.