FDA Device recall Z-0916-2014
Stand-Alone Resuscitation, T-Piece, part numbers 2063771-001, 2063772-001, 2063773-001, 2063774-001, 2063775-001, M1226442, M1241420, M1241…
- FDA Device
- Class II
- terminated
- Published 2014-02-12
On 2014-02-12 the FDA classified a Class II recall of Stand-Alone Resuscitation, T-Piece, part numbers 2063771-001, 2063772-001, 2063773-001, 2063774-001, 2063775-001, M1226442, M1241420, M1241… by Ge Healthcare, citing medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0916-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-12-12 |
| Published | 2014-02-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
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.
Reason
Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.
Identifiers
| code_info | Serial Numbers: QABR50001 QABR50002 QABR50003 QABR50004 QABR50005 QABR50006 QABR50007 QABR50008 QABR50009 QAB…Serial Numbers: 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 QABR50061 QABR50062 QABR50063 QABR50077 QABR50078 QABR50079 QABR50080 QABR50081 QABR50082 QABR50083 QABR50084 QABR50085 QABR50093 QABR50094 QABR50095 QABR50096 QABR50097 QABR50098 QABR50099 QABR50109 QABR50110 QABR50111 QABR50112 QABR50113 QABR50114 QABR50115 QABR50120 QABR50121 QABR50124 QABR |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0916-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.