Device recall

Z-0056-2010: Drager Medical Infant Manual Pulmonary Resuscitator with reservoir bag, face…

FDA device recall · Class I · Unomedical

Key facts

Recall number (Z-number) Z-0056-2010
Recall event 53489
Product Drager Medical Infant Manual Pulmonary Resuscitator with reservoir bag, face mask and swivel gas sampling elbow, Peep Valve. Product code: 40-116733, Distribution to France only.
Product code BTM
Recalling firm Unomedical
Recall class Class I
Status Terminated
Termination date Aug 10, 2010
510(k) numbers K873286
FEI number 1000160240

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 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)