Device recall

Z-0121-2022: P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641

FDA device recall · Class II · Fort Defiance Industries, LLC

Key facts

Recall number (Z-number) Z-0121-2022
Recall event 88628
Product P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641
Product code FLE
Recalling firm Fort Defiance Industries, LLC
Recall class Class II
Status Open, Classified
510(k) numbers K141009
FEI number 3011421558

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

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