FDA Device recall Z-0915-2014
Stand-Alone Resuscitation Unit, Bag and Mask, Upgrade Kits, part number M1139612, 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 Stand-Alone Resuscitation Unit, Bag and Mask, Upgrade Kits, part number M1139612, 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-0915-2014 |
| 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, Upgrade Kits, part number M1139612, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com*** Provides the basic equipment required for pulmonary resuscitation of infant.s
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: 402055 402149 402151 402155 402168 402172 402134 401758 401759 401760 401761 401762 401767…Serial Numbers: 402055 402149 402151 402155 402168 402172 402134 401758 401759 401760 401761 401762 401767 401769 401772 401775 401776 401825 401773 401777 401771 401774 401778 401766 401763 401764 401765 401768 401770 400802 400657 400434 400768 401203 401208 402081 402245 402180 401965 400493 400504 400506 401998 402345 402352 400311 401481 410773 |
|---|
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-0915-2014%22
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