The QMN Weekly Bulletin
Medical Devices / Postmarket Safety

Cook Pulls Venous Catheters, Pressure Monitoring Sets

May 27, 2016
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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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