Stoughton, MA, United States
Beeken Biomedical, LLC recalls
1 recall recorded since 2018, most recently on 14 October 2021. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 14 October 2021
- Reason
- Endotoxin levels exceeded allowable limits.
- Distribution
- US in the state of MO
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0309-2022
- NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.