Device recall

Z-0356-2017: Contact Detach, 8mm, 23", G29; Contact Detach 8 mm, 43", G29; Contact Detach…

FDA device recall · Class II · Unomedical As

Key facts

Recall number (Z-number) Z-0356-2017
Recall event 74242
Product Contact Detach, 8mm, 23", G29; Contact Detach 8 mm, 43", G29; Contact Detach, 6mm, 23" G29; Infusion Set, Contact Detach, 6mm x 23"; Infusion Set, Contact Detach, 6mm x 32"; Infusion Set, Contact Detach, 8mm x 23"; Infusion Set, Contact Detach, 8mm x 32" The products are used in combination with…
Product code FPA
Recalling firm Unomedical As
Recall class Class II
Status Terminated
Termination date Nov 16, 2016
510(k) numbers K041545
FEI number 1000477110

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 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)