Device recall

Z-0771-2017: RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 FR…

FDA device recall · Class II · Teleflex Medical

Key facts

Recall number (Z-number) Z-0771-2017
Recall event 75781
Product RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 FR, Rx Only, Sterile, Intermittent self-catheterization
Product code KOD
Recalling firm Teleflex Medical
Recall class Class II
Status Terminated
Termination date Nov 24, 2017
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)