Giraffe and Panda Bag and Mask Resuscitation System

• • Ongoing Z-2357-2026 FDA Class I ·initiated 8 May 2026

  Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.

• 2 recalls, same reason

  • Terminated Z-0915-2014 FDA Class II ·initiated 12 Dec 2013
  • Terminated Z-0914-2014 FDA Class II ·initiated 12 Dec 2013

  Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.

• 2 recalls, same reason

  • Terminated Z-1071-2014 FDA Class I ·initiated 1 Oct 2013
  • Terminated Z-0749-2013 FDA Class I ·initiated 15 Oct 2012

  Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.

510(k) Number

K070247 ↗

FDA Product Code

BTM

Device Class

Class II

Regulation

21 CFR Part 868.5915

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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