Device recall

Z-0982-03: V*CARE, Infant Resuscitator, with 40 cm HO Pressure Limiting System & Pressure…

FDA device recall · Class III · Ventlab Corporation

Key facts

Recall number (Z-number) Z-0982-03
Recall event 26369
Product V*CARE, Infant Resuscitator, with 40 cm HO Pressure Limiting System & Pressure Port Adapter, VN 3000 Series, Non-Sterile. The product included a clear plastic bag with white background which included Direction for Use statement #5. To remove vomitus: Disconnect resuscitator from patient. Tap the…
Product code BTM
Recalling firm Ventlab Corporation
Recall class Class III
Status Terminated
Termination date Aug 7, 2003
FEI number 1314417

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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