CLASS II ONGOING Device recall · Reported 8 Dec 2021 · FDA Enforcement Report
NuStat 8" x12" Trauma Pad XR Hemafiber For temporary recalled
Beeken Biomedical is recalling NuStat 8" x12" Trauma Pad XR Hemafiber For temporary control of internal organ space, distributed in Missouri. The recall was initiated on 14 Oct 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0309-2022
- FDA event ID
- 88941
- Recalling firm
- Beeken Biomedical, Stoughton, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 Oct 2021
- FDA classified
- 26 Nov 2021
- Reported
- 8 Dec 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 14 Oct 2021 | Recall initiated by company | |
| 26 Nov 2021 | Classified by FDA | +43 days |
| 8 Dec 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Endotoxin levels exceeded allowable limits.
Product as listed by the FDA
NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5
Where it was distributed
US in the state of MO
Questions about this recall
Is NuStat 8" x12" Trauma Pad XR Hemafiber For temporary control of internal organ space recalled?
Yes. Beeken Biomedical recalled NuStat 8" x12" Trauma Pad XR Hemafiber For temporary control of internal organ space on 14 Oct 2021. The recall is Class II and its status is Ongoing. Recall number Z-0309-2022.
Why was it recalled?
Endotoxin levels exceeded allowable limits.
Which lots are affected?
Lot Code: 20C015 UDI: 00850392006544
Where was it sold?
US in the state of MO
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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