Medical Device Safety and Recalls: Resuscitation Systems with Oxygen and Air inlet Fittings Reversed During Assembly

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Resuscitation Systems with Oxygen and Air inlet Fittings Reversed During Assembly

The oxygen and air wall inlet fittings on the back panel of the resuscitation systems listed below 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.

• 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

For more information, including the affected lot numbers, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm387700.htm

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