Device recall

Z-2446-2024: Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 560…

FDA device recall · Class I · Covidien

Key facts

Recall number (Z-number) Z-2446-2024
Recall event 94855
Product Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 560 VENTILATOR/4096600, PURITAN BENNETT PB560 VENTILATOR EU-DIV/4096600-01, PURITAN BENNETT 560 VENTILATOR JAPAN/4096600-02, PURITAN BENNETT 560 VENTILATOR APAC/4096600-03, Puritan Bennett 560 Ventilator LATAM/4096600-04…
Product code CBK
Recalling firm Covidien
Recall class Class I
Status Open, Classified
510(k) numbers K070899
FEI number 2024500

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)