Manual Resuscitator with Ace

• • Terminated Z-1880-2016 FDA Class II ·initiated 15 Mar 2016 ·on shared 510(k) K982215

  Stat-check CO2 indicators are non-functional. The indicator is yellow when not in use and should be purple when not in use. The yellow indicates a 5% CO2 level, cardiac massage and ventiliation being performed correctly. The color will not change during use and will not be an indicator of CO2 level or improper performance of cardiac message and ventilation.

• • Terminated Z-1948-2014 FDA Class I ·initiated 16 May 2014

  The pop-off valve in the defective devices remain open and a squeeze of the bag may not generate enough force to force the duck bill valve open and therefore no air will be delivered to the victim.

• • Terminated Z-0172-2013 FDA Class I ·initiated 11 Jul 2012

  Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

• 5 recalls, same reason

  • Terminated Z-0893-04 FDA Unclassified (pre-2012) ·initiated 26 Mar 2004
  • Terminated Z-0892-04 FDA Unclassified (pre-2012) ·initiated 26 Mar 2004
  • Terminated Z-0891-04 FDA Unclassified (pre-2012) ·initiated 26 Mar 2004
  • Terminated Z-0894-04 FDA Unclassified (pre-2012) ·initiated 26 Mar 2004
  • Terminated Z-0895-04 FDA Unclassified (pre-2012) ·initiated 26 Mar 2004

  In some cases the device may develop small cracks that could expand over time and result in reduced shelf life or other failure.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K982215 ↗

FDA Product Code

BTM

Device Class

Class II

Regulation

21 CFR Part 868.5915

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Resposable Infant Resuscitator

  Class II

  FDA 510(k) K961882 Active Cleared 28 Jun 1996

• Resposable Resuscitator

  Class II

  FDA 510(k) K953617 Active Cleared 22 Nov 1995

• Bagright Resuscitator

  Class II

  FDA 510(k) K954296 Active Cleared 20 Dec 1995

• Resposable Child Resuscitator

  Class II

  FDA 510(k) K961868 Active Cleared 28 Jun 1996

• Bagright Resposable Child Resuscitator

  Class II

  FDA 510(k) K961331 Active Cleared 28 Jun 1996

• Anesthesia/Respiratory Face Mask

  Class I

  FDA 510(k) K953107 Active Cleared 15 Aug 1995

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