Device recall

Z-0131-2009: 18 gage XTW needles, sold as a component in SafeSheath Hemostatic Tear-away…

FDA device recall · Class II · Thomas Medical Products Inc

Key facts

Recall number (Z-number) Z-0131-2009
Recall event 49531
Product 18 gage XTW needles, sold as a component in SafeSheath Hemostatic Tear-away Introducer System with Infusion Side Port kits or sold Bulk Non Sterile (BNS).
Product code DYB
Recalling firm Thomas Medical Products Inc
Recall class Class II
Status Terminated
Termination date May 6, 2009
510(k) numbers K003731
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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