🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: October 14, 2021 Beeken Biomedical Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Lot Code: 20C015 UDI: 00850392006544
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Beeken Biomedical, LLC
Reason for Recall:
Endotoxin levels exceeded allowable limits.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

Lot Code: 20C015 UDI: 00850392006544

Distribution:

Distributed in: US, MO

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0309-2022