Device recall

Z-0436-06: Smiths Pneupac babyPAC portable ventilator, model 100. Designed for use by…

FDA device recall · Class II · Smiths Medical PM, Inc.

Key facts

Recall number (Z-number) Z-0436-06
Recall event 34275
Product Smiths Pneupac babyPAC portable ventilator, model 100. Designed for use by qualified medical caregivers, paramedics and other trained personnel, for hospital, emergency and transport ventilation of patients during respiratory distress or insufficiency.
Product code BTL
Recalling firm Smiths Medical PM, Inc.
Recall class Class II
Status Terminated
Termination date Dec 26, 2006
FEI number 2183502

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

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