The Recall Desk
Agency classClass IOur severity:SevereFDA (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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly."

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 →

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