FDAMay 25, 2022device

MERIT MEDICAL SYSTEMS StayFIX FIXATION DEVICE, STAYFIX F/PERCUTAN CATH 5FR-14FR Model Number: 884450023358. Used to secure anaesthesia catheter.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. This device with this specific storage temperature deviation is not likely to cause adverse health consequences.

What to do

FDA enforcement status: Ongoing

Brands named

mckesson medical surgical inc corporate officemckessonmckesson medical

UPCs

008844500233581088445002335520884450023352884450023358

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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