Reported Feb 12, 2014 · Terminated
Stand-Alone Resuscitation Unit, Bag and Mask, Upgrade Kits, part number M1139612, labeled in part ***GE Healthcare 8880…
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, Upgrade Kits, part number M1139612, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com*** Provides the basic equipment required for pulmonary resuscitation of infant.s
- Lot codes and dates
- Serial Numbers
402055402149402151402155402168402172402134401758401759401760401761401762401767401769401772401775401776401825401773401777401771401774401778401766401763401764401765401768401770400802400657400434400768401203401208402081402245402180401965400493400504400506401998402345402352400311401481410773
- Serial Numbers
- Amount recalled
- 48 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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