Device recall

Z-0227-2023: Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit…

FDA device recall · Class II · TELEFLEX LLC

Key facts

Recall number (Z-number) Z-0227-2023
Recall event 90962
Product Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116). Urinary catheter.
Product code KOD
Recalling firm TELEFLEX LLC
Recall class Class II
Status Open, Classified
510(k) numbers K010420
FEI number 3005747797

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)