Device recall

Z-1377-2024: Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b)…

FDA device recall · Class II · Baxter Healthcare Corporation

Key facts

Recall number (Z-number) Z-1377-2024
Recall event 94152
Product Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b) PC0608NBIO, c) PC0814NBIO, d) PC1016NBIO
Product code FTM
Recalling firm Baxter Healthcare Corporation
Recall class Class II
Status Open, Classified
510(k) numbers K983162
FEI number 1417572

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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)