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Mckesson Medical-Surgical Inc. Corporate Office recalls MERIT MEDICAL SYSTEMS StayFIX FIXATION DEVICE, STAYFIX F/PERCUTAN CATH 5FR-14FR Model Number: 884450023358. Used to sec
Recalled October 5, 2022 · FDA recall Z-1797-2022 · Mckesson Medical-Surgical Inc. Corporate Office
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. · FDA Class III
Units
109
Sold at
US Nationwide distribution.
Description
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.
Product
MERIT MEDICAL SYSTEMS StayFIX FIXATION DEVICE, STAYFIX F/PERCUTAN CATH 5FR-14FR Model Number: 884450023358. Used to secure anaesthesia catheter.
Manufacturer(s)
Mckesson Medical-Surgical Inc. Corporate Office
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →