Recalled Medical Product Lacked FDA 510(k) Approval

Medical Device Recalled | In Compliance MagazineIn conjunction with the U.S. Food and Drug Administration (FDA), ConvaTec, Inc. has initiated a recall of its Flexi-Seal CONTROL-brand fecal management systems. Fecal management systems are temporary containment devices used with incontinent patients.

According to a press release issued by the FDA, the voluntary recall was initiated following a determination that the device should have received independent 510(k) clearance from the FDA, instead of a “note to file” based on an existing Flexi-Seal 510(k) clearance.

In addition, ConvaTec has reportedly received reports from U.S. healthcare facilities of 13 adverse events in connection with patients using the recalled device, including 12 serious injuries and one death, during the period from February 2013 to March 2014. Concern has focused on an auto-valve feature in the device that may not have performed consistently during normal operations.

Read the FDA press release regarding this medical device recall.

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