Z-0309-2022 Class II Ongoing

Recalled by Beeken Biomedical, LLC — Stoughton, MA

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