FDA recall Z-0309-2022
Beeken Biomedical, LLC · Class II · device
Product
NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5
Reason for recall
Endotoxin levels exceeded allowable limits.
Distribution
US in the state of MO
Key facts
- Status
- Ongoing
- Initiation date
- 2021-10-14
- Report date
- 2021-12-08
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Stoughton, MA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0309-2022