FDA recall Z-0055-2021
Medline Industries Inc · Class II · device
Product
Quick Release Gait Belt, 60
Reason for recall
The buckle on the Gait Belt may break due to degradation of the material due to exposure to gamma radiation.
Distribution
Domestic Distribution Only: IL, MI
Key facts
- Status
- Ongoing
- Initiation date
- 2020-09-15
- Report date
- 2020-10-14
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Northfield, IL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0055-2021