Disposable, Manual Pulmonary Resuscitator

• 23 recalls, same reason

  • Terminated Z-0045-2010 FDA Unclassified (pre-2012) ·initiated 6 Oct 2009
  • Terminated Z-0039-2010 FDA Unclassified (pre-2012) ·initiated 6 Oct 2009
  • Terminated Z-0047-2010 FDA Unclassified (pre-2012) ·initiated 6 Oct 2009
  • Terminated Z-0050-2010 FDA Unclassified (pre-2012) ·initiated 6 Oct 2009
  • Terminated Z-0071-2010 FDA Unclassified (pre-2012) ·initiated 6 Oct 2009
  • Terminated Z-0041-2010 FDA Unclassified (pre-2012) ·initiated 6 Oct 2009
  • Terminated Z-0051-2010 FDA Unclassified (pre-2012) ·initiated 6 Oct 2009
  • Terminated Z-0052-2010 FDA Unclassified (pre-2012) ·initiated 6 Oct 2009
  • Terminated Z-0054-2010 FDA Unclassified (pre-2012) ·initiated 6 Oct 2009
  • Terminated Z-0058-2010 FDA Unclassified (pre-2012) ·initiated 6 Oct 2009
  • Terminated Z-0048-2010 FDA Unclassified (pre-2012) ·initiated 6 Oct 2009
  • Terminated Z-0043-2010 FDA Unclassified (pre-2012) ·initiated 6 Oct 2009
  • Terminated Z-0057-2010 FDA Unclassified (pre-2012) ·initiated 6 Oct 2009
  • Terminated Z-0049-2010 FDA Unclassified (pre-2012) ·initiated 6 Oct 2009
  • Terminated Z-0044-2010 FDA Unclassified (pre-2012) ·initiated 6 Oct 2009
  • Terminated Z-0055-2010 FDA Unclassified (pre-2012) ·initiated 6 Oct 2009
  • Terminated Z-0070-2010 FDA Unclassified (pre-2012) ·initiated 6 Oct 2009
  • Terminated Z-0072-2010 FDA Unclassified (pre-2012) ·initiated 6 Oct 2009
  • Terminated Z-0040-2010 FDA Unclassified (pre-2012) ·initiated 6 Oct 2009
  • Terminated Z-0042-2010 FDA Unclassified (pre-2012) ·initiated 6 Oct 2009
  • Terminated Z-0046-2010 FDA Unclassified (pre-2012) ·initiated 6 Oct 2009
  • Terminated Z-0053-2010 FDA Unclassified (pre-2012) ·initiated 6 Oct 2009
  • Terminated Z-0056-2010 FDA Unclassified (pre-2012) ·initiated 6 Oct 2009

  In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pressure necessary necessary to ventilate the patient.

510(k) Number

K873286 ↗

FDA Product Code

BTM

Device Class

Class II

Regulation

21 CFR Part 868.5915

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Disposable Aerosol T

  Class I

  FDA 510(k) K791538 Active Cleared 7 Sep 1979

• Disposable Medication Nebulizer

  Class II

  FDA 510(k) K791536 Active Cleared 7 Sep 1979

• Breathing Circuit Products, Anesthesia

  Class I

  FDA 510(k) K781908 Active Cleared 27 Nov 1978

• Disposable Mouthpiece

  Class I

  FDA 510(k) K791537 Active Cleared 7 Sep 1979

• Inflatable Air Splints

  Class I

  FDA 510(k) K853600 Active Cleared 19 Sep 1985

• Disposable Incentive Spirometer

  Class II

  FDA 510(k) K792598 Active Cleared 4 Jan 1980

See all devices from Hospitak, Inc. →