10 Biggest Medical Device Recalls of 2016—Cook Medical

Device: Cook Medical's Single Lumen Central Venous Catheter Sets and Trays; Single Lumen Pressure Monitoring Sets and Trays; Femoral Artery Pressure Monitoring Catheter Sets and Trays; Radial Artery Pressure Monitoring Catheter Sets and Trays. Click here for affected lot numbers.

Recall reason: According to information on the FDA recall page, "the tips may split or separate from the catheters due to a manufacturing error . . . the tip could enter the patient's blood stream. This could cause serious injury to the patient . . . or cause death. Tip splitting or separation may also cause the device to stop working."

At the time, FDA said it had 13 medical device reports of serious adverse events and one death.

When recall was initiated: January 6, 2016

Number of U.S. units impacted: 12,516 units

For more information, visit the FDA Recall page.

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