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
    • QABS50026
    • QABR50066
    • QABR50068
    • QABR50133
    • QABS50023
    • QABR50102
    • QABR50103
    • QABR50064
    • QABR50065
    • QABR50067
    • QABS50070
    • QABS50069
    • QABR50275
    • QABS50027
    • QABR50274
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 1, 2015 · Data as of Sep 19, 5:35 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.