CLASS II Device recall · Reported 12 Feb 2014 · FDA Enforcement Report

Stand-Alone Resuscitation Unit, Bag and Mask recalled by GE Healthcare

GE Healthcare is recalling Stand-Alone Resuscitation Unit, Bag and Mask, distributed nationwide in the US. The recall was initiated on 12 Dec 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: QABS50026 QABR50066 QABR50068 QABR50133 QABS50023 QABR50102 QABR50103 QABR50064 QABR50065 QABR50067 QABS50070 QABS50069 QABR50275 QABS50027 QABR50274

Quantity recalled15 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0914-2014
FDA event ID: 67225
Recalling firm: GE Healthcare, Laurel, MD
Classification: Class II
Status: Terminated
Recall initiated: 12 Dec 2013
FDA classified: 3 Feb 2014
Reported: 12 Feb 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Masks, Gloves & PPE

Timeline

12 Dec 2013	Recall initiated by company
3 Feb 2014	Classified by FDA	+53 days
12 Feb 2014	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.

Product as listed by the FDA

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.

Where it was distributed

Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Uruguay, Venezuela, Albania, Algeria, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Canada, Chile, China, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Kazakhstan, Korea, Kuwait, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates, and United Kingdom.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.

Which lots are affected?

Serial Numbers: QABS50026 QABR50066 QABR50068 QABR50133 QABS50023 QABR50102 QABR50103 QABR50064 QABR50065 QABR50067 QABS50070 QABS50069 QABR50275 QABS50027 QABR50274

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 67225

This product is part of a recall event; the main page for the event is Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417 recalled.

Reported	Class	Recall	Company	Reason	Where
12 Feb 2014	CLASS II	Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417 recalled	GE Healthcare	Other	Nationwide
12 Feb 2014	CLASS II	Stand-Alone Resuscitation, T-Piece recalled by GE Healthcare	GE Healthcare	Other	Nationwide
12 Feb 2014	CLASS II	Giraffe¿ Infant Warmers recalled by GE Healthcare	GE Healthcare	Other	Nationwide
12 Feb 2014	CLASS II	Stand-Alone Resuscitation Unit, Bag and Mask, Upgrade Kits recalled	GE Healthcare	Other	Nationwide

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