FDA recall Z-0211-2022
Z-Medica, LLC · Class II · device
Product
QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200
Reason for recall
Lack of Packaging seal integrity may result in a sterile barrier breach.
Distribution
US Nationwide distribution in the state of NC.
Key facts
- Status
- Terminated
- Initiation date
- 2021-09-22
- Report date
- 2021-11-17
- Termination date
- 2024-06-11
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Wallingford, CT, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0211-2022