The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0914-2014·Announced 2014-02-12

GE Healthcare Recalls Infant Resuscitation Units Due to Loose Adjustment Knob

GE Healthcare is recalling 15 infant resuscitation units because a loose adjustment knob may affect the accuracy of the blended Air/Oxygen gas mixture.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device used for infant resuscitation where a defect may affect the accuracy of the gas mixture. This represents a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

GE Healthcare is recalling 15 units of the Stand-Alone Resuscitation Unit, Bag and Mask (part number M1226444). The recall is due to a defect where the adjustment knob may be loose, which can affect the accuracy of the blended Air/Oxygen gas mixture delivered to patients.

The affected units are intended to provide basic equipment for the pulmonary resuscitation of infants. The recall covers 15 specific units with serial numbers QABS50026, QABR50066, QABR50068, QABR50133, QABS50023, QABR50102, QABR50103, QABR50064, QABR50065, QABR50067, QABS50070, QABS50069, QABR50275, QABS50027, and QABR50274.

These units were distributed worldwide, including the United States (nationwide), Puerto Rico, and numerous countries across the Americas, Europe, Asia, Africa, and the Middle East. Healthcare facilities and consumers should check their inventory for these specific serial numbers and stop using the affected units. GE Healthcare is the recalling firm.

The recalled product

Product
Stand-Alone Resuscitation Unit, Bag and Mask, part number M1226444, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com***. Provides the basic equipment required for pulmonary resuscitation of infants.
Manufacturer
GE Healthcare
Category
Medical Device — Resuscitation Equipment
Hazard
Affected units
15

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 6 recalled by GE Healthcare 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 6 products in this recall →

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