Wauwatosa, Wis.-based GE Healthcare has issued a Class I recall of its infant resuscitation systems because the oxygen and air inlet fittings were reversed during assembly.
The affected products could disrupt appropriate oxygen delivery, potentially leading to either extra high or low blood oxygen levels, which could cause death in infants.
The following are the potential affected resuscitation systems.
- 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
Affected products were assembled between April 1, 2007 and Oct. 31, 2013 and were distributed between Oct. 1, 2007 and Oct. 31, 2013.
Visit the FDA's recall page for a list of affected product lot numbers.
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