Reported Feb 12, 2014 · Terminated
Stand-Alone Resuscitation Unit, Bag and Mask, part number M1226444, labeled in part ***GE Healthcare 8880 Gorman Road…
GE Healthcare
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare · 8880 Gorman Rd · Laurel, MD · 20723-5800
Is this the product you have?
- 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.
- Lot codes and dates
- Serial Numbers
QABS50026QABR50066QABR50068QABR50133QABS50023QABR50102QABR50103QABR50064QABR50065QABR50067QABS50070QABS50069QABR50275QABS50027QABR50274
- Serial Numbers
- Amount recalled
- 15 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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