Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0309-2022 — NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5

U.S. FDA — Device Enforcement · United States · 2021-10-14 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0309-2022
Date of alert
2021-10-14
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Beeken Biomedical, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00850392006544
Reported risk: Endotoxin levels exceeded allowable limits.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.