FDA Device recall Z-0914-2014
Stand-Alone Resuscitation Unit, Bag and Mask, part number M1226444, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723***ww…
- FDA Device
- Class II
- terminated
- Published 2014-02-12
On 2014-02-12 the FDA classified a Class II recall of Stand-Alone Resuscitation Unit, Bag and Mask, part number M1226444, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723***ww… 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-0914-2014 |
| 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 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.
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: QABS50026 QABR50066 QABR50068 QABR50133 QABS50023 QABR50102 QABR50103 QABR50064 QABR50065 QAB…Serial Numbers: QABS50026 QABR50066 QABR50068 QABR50133 QABS50023 QABR50102 QABR50103 QABR50064 QABR50065 QABR50067 QABS50070 QABS50069 QABR50275 QABS50027 QABR50274 |
|---|
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-0914-2014%22
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