FDAnews Device Daily Bulletin
Medical Devices / Postmarket Safety

Carefusion Issues Class I Recall on Laparoscopes, Ventilators

Aug. 2, 2016

Carefusion issued an urgent recall of several of its laparoscopes, including the DiamondFlex circular retractor and the Snowden-Pencer.

The Class I recall was issued because BD, formerly Carefusion, identified a weld failure that could result in the wire protruding through the tip of the instrument, which could damage tissues or organs. Customers were instructed to return the affected devices.

The same week, the company turned around to issue another Class I recall for its AVEA ventilators due to an electrical issue that could cause the device to shut down unexpectedly.

The AVEA recall affects 501 units distributed in the U.S. — Tamra Sami

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