Device recall

Z-3005-2026: Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY…

FDA device recall · Class II · AVID Medical, Inc.

Key facts

Recall number (Z-number) Z-3005-2026
Recall event 99527
Product Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27
Product code LRO
Recalling firm AVID Medical, Inc.
Recall class Class II
Status Open, Classified
FEI number 1047429

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1,000+ 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)