Device recall

Z-0057-05: SafeSheath KR under the Pressure Products label. Tearaway KR Kit. Catalog number…

FDA device recall · Class II · Thomas Medical Products Inc

Key facts

Recall number (Z-number) Z-0057-05
Recall event 30242
Product SafeSheath KR under the Pressure Products label. Tearaway KR Kit. Catalog number HLS/KR-1009. The product is shipped in cartons containing 5 units.
Product code DYB
Recalling firm Thomas Medical Products Inc
Recall class Class II
Status Terminated
Termination date Jan 24, 2006
FEI number 3010665433

At a glance

  • None 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)