Giraffe and Panda T- Piece Resuscitation System

• 2 recalls, same reason

  • Terminated Z-0916-2014 FDA Class II ·initiated 12 Dec 2013
  • Terminated Z-0917-2014 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-1070-2014 FDA Class I ·initiated 1 Oct 2013
  • Terminated Z-0748-2013 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.

• • Terminated Z-0606-2013 FDA Class I ·initiated 26 Jun 2012

  Disposable T-Piece circuits used with resuscitation systems are unable to achieve maximum Peak Inspiratory Pressure (PIP) during the pre-use check out procedure.

510(k) Number

K070210 ↗

FDA Product Code

BTL

Device Class

Class II

Regulation

21 CFR Part 868.5925

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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