The Recall Desk
ModerateFDA (Devices)·Z-1071-2014·Announced 2014-03-05

GE Healthcare Recalls Infant Resuscitation Systems Due to Reversed Fittings

GE Healthcare is recalling Giraffe and Panda infant resuscitation systems because oxygen and air inlet fittings were reversed during assembly.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class I, which is typically associated with a reasonable probability of serious adverse health consequences. However, the source text does not report any specific injuries, illnesses, or deaths, and the defect is a manufacturing assembly error rather than a high-risk pathogen or structural failure leading to immediate harm. Therefore, it is rated as Moderate.

Plain-English summary

GE Healthcare, LLC is recalling the Giraffe and Panda Bag and Mask Resuscitation System and the Giraffe Stand-alone Infant Resuscitation System. These devices are used for pulmonary resuscitation of infants, a clinical practice representing the established standard of care.

The recall is due to a manufacturing error where the oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly. This defect could potentially affect the delivery of oxygen or air/oxygen mixtures during manual ventilation.

A total of 12,373 units are affected by this recall, with 8,807 units distributed in the United States, 3,394 units distributed outside the United States, and 172 units with unknown distribution. The products were distributed nationwide in the US and in numerous countries worldwide. Users should contact GE Healthcare for instructions on how to resolve the issue.

The recalled product

Product
GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe Stand-alone Infant Resuscitation System. Product Usage: The Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Resuscitation Equipment
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (15)

  • QABS50026
  • QABR50066
  • QABR50068
  • QABR50133
  • QABS50023
  • QABR50102
  • QABR50103
  • QABR50064
  • QABR50065
  • QABR50067
  • QABS50070
  • QABS50069
  • QABR50275
  • QABS50027
  • QABR50274

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

Part of a larger recall action

This product is one of 3 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · GE Healthcare, LLC

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Same hazard · mis assembly

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