Reported Feb 12, 2014 · Terminated

Stand-Alone Resuscitation, T-Piece, part numbers 2063771-001, 2063772-001, 2063773-001, 2063774-001, 2063775-001,…

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, T-Piece, part numbers 2063771-001, 2063772-001, 2063773-001, 2063774-001, 2063775-001, M1226442, M1241420, M1241421, M1241424, M1241425, M1241427, M1241430, M1241461, M1241463, M1241464, and M1241589; 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

    375 of 375 codes

    • QABR50001
    • QABR50002
    • QABR50003
    • QABR50004
    • QABR50005
    • QABR50006
    • QABR50007
    • QABR50008
    • QABR50009
    • QABR50010
    • QABR50011
    • QABR50012
    • QABR50013
    • QABR50014
    • QABR50015
    • QABR50016
    • QABR50017
    • QABR50018
    • QABR50019
    • QABR50020
    • QABR50021
    • QABR50022
    • QABR50023
    • QABR50024
    • QABR50025
    • QABR50026
    • QABR50027
    • QABR50028
    • QABR50029
    • QABR50030
    • QABR50031
    • QABR50032
    • QABR50033
    • QABR50034
    • QABR50035
    • QABR50036
    • QABR50037
    • QABR50038
    • QABR50039
    • QABR50040
    • QABR50041
    • QABR50042
    • QABR50043
    • QABR50044
    • QABR50045
    • QABR50046
    • QABR50047
    • QABR50048
    • QABR50049
    • QABR50050
    • QABR50051
    • QABR50052
    • QABR50053
    • QABR50054
    • QABR50055
    • QABR50056
    • QABR50057
    • QABR50058
    • QABR50059
    • QABR50060
Amount recalled
375 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, 5:34 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.