FDA Device recall Z-0917-2014
Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M1223628, labeled in part ***GE Healthcare 8880 Gorman Road Laurel…
- FDA Device
- Class II
- terminated
- Published 2014-02-12
On 2014-02-12 the FDA classified a Class II recall of Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M1223628, labeled in part ***GE Healthcare 8880 Gorman Road Laurel… 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-0917-2014 |
| 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
Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M1223628, 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: 100341 100342 100348 200118 200143 200513 200522 200590 200598 200617 201111 201375 201384…Serial Numbers: 100341 100342 100348 200118 200143 200513 200522 200590 200598 200617 201111 201375 201384 201409 201424 201567 201621 201622 201625 201627 201814 202013 202021 202141 202143 202147 202280 202300 202365 202395 202439 202538 203117 203186 203419 203448 203452 203453 203755 203961 204048 204153 204154 204166 204170 204323 204333 204732 204848 204858 204882 204888 204896 204898 204904 204906 204908 205060 205062 205074 205076 205077 205078 205079 205095 205096 205098 205101 205105 205106 205110 205114 205115 205118 205121 205124 205129 205131 205132 205133 205134 205135 205136 205137 205139 205140 205141 205142 205143 205144 205145 205146 205147 205148 205150 205151 205152 205164 205169 205233 205238 205239 205285 205324 205326 205328 205331 205341 205355 205380 205461 205475 205481 205531 205547 205557 205561 205628 205629 205630 205632 205635 205699 |
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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-0917-2014%22
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