Device recall

Z-0971-2011: Bio Med Devices Disposable Pediatric Breathing Circuit, One Set, Catalog Number…

FDA device recall · Class II · Biomed Devices

Key facts

Recall number (Z-number) Z-0971-2011
Recall event 57051
Product Bio Med Devices Disposable Pediatric Breathing Circuit, One Set, Catalog Number: 4040LC-9 9 foot /15mm corrugated EVA hose Intended use: Breathing circuit is a pediatric disposable tubing assembly for use with Lifecare ventilator
Product code CBK
Recalling firm Biomed Devices
Recall class Class II
Status Terminated
Termination date Oct 23, 2014
FEI number 3003952420

At a glance

  • None 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)