FDA recall Z-1797-2022

Mckesson Medical-Surgical Inc. Corporate Office · Class III · device

Product

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

Reason for recall

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.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2022-05-25
Report date
2022-10-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Richmond, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1797-2022