Catheter sterility concerns prompt Class 1 FDA recall for surgery trays

Editor's Note

The US Food and Drug Administration has designated DeRoyal Industries’ recall of GeoMed custom tracecarts a class 1, the most serious type of recall indicating a risk of serious injury or death.

According to the April 24 FDA notice, the recall is due to sterility concerns with the sterility of the Nurse Assist LLC 16FR Silver Urine Meter Foley, a urinary catheter with a measuring meter that is included in the surgical trays. Nurse Assist LLC recalled that product in November. The rest of the items in the surgical trays, which include drapes and accessories to maintain a sterile field, prevent contamination, and help organize surgical supplies, are not affected.

So far, there have been no reported injuries or deaths. According to FDA, DeRoyal sent an urgent recall notice to affected customers on February 13 urging them to place affected surgical packs in quarantine, return any Nurse Assist 16FR Urine Meter Foley units, and inform all locations where these products have been distributed about the recall.