Device recall

Z-0125-06: Sheath Obturator, introducer, catheter. Obturator Accessory Kit Reorder number…

FDA device recall · Class III · St. Jude Medical / Daig Division

Key facts

Recall number (Z-number) Z-0125-06
Recall event 33702
Product Sheath Obturator, introducer, catheter. Obturator Accessory Kit Reorder number 406405, a 6 Fr, 15 cm length Obturator supplied as a 10-pack box with 10 Individually packaged Obturators. Sterile EO. Single use. St. Jude medical, DAIG Division, Inc., Minnetonka, MN 55345-2126 USA
Product code DYB
Recalling firm St. Jude Medical / Daig Division
Recall class Class III
Status Terminated
Termination date Jul 22, 2006
510(k) numbers K884494
FEI number 2182269

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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