PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: December 8, 2021 Initiated: October 14, 2021 #Z-0309-2022

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.

Details

Recalling Firm
Beeken Biomedical, LLC
Units Affected
15 units
Distribution
US in the state of MO
Location
Stoughton, MA

Frequently Asked Questions

What product was recalled?
NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5. Recalled by Beeken Biomedical, LLC. Units affected: 15 units.
Why was this product recalled?
Endotoxin levels exceeded allowable limits.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 8, 2021. Severity: Moderate. Recall number: Z-0309-2022.