Beeken Biomedical, LLC: Medical Device Recall in 2021 - (Recall #: Z-0309-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5

Product Classification:

Class II

Date Initiated: October 14, 2021

Date Posted: December 8, 2021

Recall Number: Z-0309-2022

Event ID: 88941

Reason for Recall:

Endotoxin levels exceeded allowable limits.

Status: Ongoing

Product Quantity: 15 units

Code Information:

Lot Code: 20C015 UDI: 00850392006544

Distribution Pattern:

US in the state of MO

Voluntary or Mandated:

Voluntary: Firm initiated