Device recall

Z-1855-2021: WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012

FDA device recall · Class II · Abbott Laboratories Inc. (St Jude Medical)

Key facts

Recall number (Z-number) Z-1855-2021
Recall event 87904
Product WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012
Product code DQK
Recalling firm Abbott Laboratories Inc. (St Jude Medical)
Recall class Class II
Status Terminated
Termination date Jun 18, 2024
510(k) numbers K210392
FEI number 1000139754

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

Browse all FDA device recalls (products)