FDA Issues Class I Recall for GE Healthcare Resuscitation Systems
On February 28, 2014, the FDA issued a Class I Recall for GE Healthcare Resuscitation Systems with the issue being that “the oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.” The FDA warned that “[t]hese 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).”
The FDA reports that the affected products were manufactured from April 1, 2007 through October 31, 2013 and distributed from October 1, 2007 through October 31, 2013. The Class I Recall includes the following 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 to 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. The FDA has also provided a list of the affected lot numbers here.
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