Device recall

Z-0120-2010: Reinforced Catheter Introducer System, 5 per carton. The product is sold under…

FDA device recall · Class I · Thomas Medical Products Inc

Key facts

Recall number (Z-number) Z-0120-2010
Recall event 53672
Product Reinforced Catheter Introducer System, 5 per carton. The product is sold under the Cordis Crossover and Cardiovascular Systems Inc (CSI) ViperSheath labels.
Product code DYB
Recalling firm Thomas Medical Products Inc
Recall class Class I
Status Terminated
Termination date Nov 8, 2010
510(k) numbers K083269
FEI number 3010665433

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

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