Device recall

Z-1021-2020: AAMI 3 NONREINF SURG GOWN 3XL BNS, Item Code 9585N

FDA device recall · Class II · Cardinal Health

Key facts

Recall number (Z-number) Z-1021-2020
Recall event 84733
Product AAMI 3 NONREINF SURG GOWN 3XL BNS, Item Code 9585N
Product code FYA
Recalling firm Cardinal Health
Recall class Class II
Status Terminated
Termination date Jan 19, 2023
510(k) numbers K170762
FEI number 1419729

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 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)