FDA Alerts

Class I Recall: GE Healthcare, Giraffe Warmer with Resuscitation System, Panda Warmer with Resuscitation System, Giraffe Stand-Alone Infant Resuscitation System, Resuscitation System Upgrade Kits, Panda Freestanding with Resuscitation System – Issue – Oxygen and Air inlet Fittings Were Reversed During Assembly

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

Wed Mar 12 2014By Kaylee McCaffrey

 

Recall Class: Class I

Recall Initiation Date: October 1, 2013

Products:

  • Giraffe Warmer with Resuscitation System
  • Panda Warmer with Resuscitation System
  • Giraffe Stand-Alone Infant Resuscitation System
  • Resuscitation System Upgrade Kits
  • Panda Freestanding with Resuscitation System

These products are also referred as: Giraffe Warmer, Panda Warmer, Panda iRes Warmer, Giraffe and Panda IRes Infant Warmer, Giraffe and Panda Bag and Mask Resuscitation System, Giraffe and Panda Warmer TPiece, and T-Piece Resuscitation System.

Affected Lot Numbers:

The affected products were manufactured from April 1, 2007 through October 31, 2013 and distributed from October 1, 2007 through October 31, 2013.

Use: These devices are used to resuscitate infants and newborns and regulate body temperature.

Recalling Firm:
GE Healthcare
9900 Innovation Drive
Wauwatosa, Wisconsin 53226

Reason for Recall: The oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly. These recalled products may interfere with oxygen delivery resulting in inaccurate oxygen regulation in newborns (neonates) and may lead to low blood oxygen (hypoxia) or high blood oxygen (hyperoxia). This may cause death in neonates, particularly those who are critically ill. Preterm and low-birth weight babies are also at increased risk in terms of morbidity and mortality.

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