Device recall

Z-0309-2022: NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of…

FDA device recall · Class II · Beeken Biomedical, LLC

Key facts

Recall number (Z-number) Z-0309-2022
Recall event 88941
Product NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5
Product code POD
Recalling firm Beeken Biomedical, LLC
Recall class Class II
Status Open, Classified
510(k) numbers K183190
FEI number 3009348684

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)