Device recall

Z-2450-2023: Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part…

FDA device recall · Class I · Mallinckrodt Manufacturing LLC

Key facts

Recall number (Z-number) Z-2450-2023
Recall event 92799
Product Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.
Product code BZO
Recalling firm Mallinckrodt Manufacturing LLC
Recall class Class I
Status Open, Classified
FEI number 3004531588

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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)