Z-0309-2022 Class II Ongoing
FDA device recall Z-0309-2022 was initiated by Beeken Biomedical, LLC on October 14, 2021 and is designated Class II. Reason for recall: Endotoxin levels exceeded allowable limits. The recall status is ongoing. Affected quantity: 15 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 8, 2021
- Initiation Date
- October 14, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 units
Product Description
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 Pattern
US in the state of MO
Code Information
Lot Code: 20C015 UDI: 00850392006544