NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5
Summary
The FDA issued a Class II for NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of interna by Beeken Biomedical, LLC. Reason: Endotoxin levels exceeded allowable limits..
Details
Source
Device Recall
External ID
Z-0309-2022
Action Date
2021-12-08
Status
Ongoing
Category
device
Product Description
NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5
Lot/Code Info: Lot Code: 20C015 UDI: 00850392006544
Quantity Affected: 15 units
Reason for Recall
Endotoxin levels exceeded allowable limits.
Distribution
US in the state of MO
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-14
Company
Stoughton, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 131 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Beeken Biomedical, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Beeken Biomedical, LLC have FDA actions?
This is the only FDA action we have on record for Beeken Biomedical, LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0309-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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