Device recall

Z-0161-04: Reusable Catheter Passer (60 cm) SP02. One stainless steel catheter passer with…

FDA device recall · Class II · Vygon US LLC

Key facts

Recall number (Z-number) Z-0161-04
Recall event 27416
Product Reusable Catheter Passer (60 cm) SP02. One stainless steel catheter passer with T handle.
Product code FOZ
Recalling firm Vygon US LLC
Recall class Class II
Status Terminated
Termination date Nov 26, 2003
510(k) numbers K853370
FEI number 2518608

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 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)