Recall Z-0309-2022— Beeken Biomedical, LLC

Name: FDA recall Z-0309-2022
Creator: U.S. Food and Drug Administration
Published: 2021-10-14

Class II · Ongoing

Class II FDA medical device recall by Beeken Biomedical, LLC, initiated 2021-10-14. It names one FDA 510(k) clearance: K183190. Product: NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5. Reason: Endotoxin levels exceeded allowable limits..

Recalling firm: Beeken Biomedical, LLC
Classification: Class II
Status: Ongoing
Initiated: 2021-10-14
Firm location: Stoughton, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K183190 — NuStatBeeken Biomedical, LLC·cleared 2019-09-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Endotoxin levels exceeded allowable limits.

Data sourced from openFDA. This site is unofficial and independent of the FDA.