NuStat 8" x12" Trauma Pad XR Hemafiber recall: Endotoxin
NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5
Why was NuStat 8" x12" Trauma Pad XR Hemafiber recalled?
Endotoxin levels exceeded allowable limits.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Code: 20C015 UDI: 00850392006544
- Product
- NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5
- Recalling firm
- Beeken Biomedical, LLC
- Quantity
- 15 units
- Distribution
- US in the state of MO
- Recall date
- December 8, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)