FDA recall Z-1132-2022
Stradis Healthcare · Class II · device
Product
Surgical Suture Kit
Reason for recall
There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity.
Distribution
US Distribution to NC.
Key facts
- Status
- Ongoing
- Initiation date
- 2022-04-22
- Report date
- 2022-06-01
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Waukegan, IL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1132-2022