FDA recall Z-0865-2022
Stradis Medical, LLC dba Stradis Healthcare · Class II · device
Product
Anterior Hip Pack - Surgical Kit
Reason for recall
The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
Distribution
US Nationwide distribution in the states of IN, TX, and PA.
Key facts
- Status
- Ongoing
- Initiation date
- 2022-02-25
- Report date
- 2022-04-13
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Peachtree Corners, GA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0865-2022