The QMN Weekly Bulletin
Medical Devices / Postmarket Safety

Cook Pulls Venous Catheters, Pressure Monitoring Sets

May 27, 2016

Cook Medical is recalling 360 specific lots of single lumen central venous catheters and pressure monitoring sets and trays due to catheter tip fracture and/or separation.

The recall, designated as Class 1 by the FDA, involves 12,516 devices distributed nationwide between April 24 and Oct. 23, 2015, according to March 30 notice.

Cook sent letters on Jan. 6 instructing customers to quarantine unused products and return the affected products to the company. Globally, the recall involves 17,827 devices.

The recall is still ongoing, company spokeswoman Moriah Sowders said.

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