Recall Z-0914-2014— GE Healthcare
Class II · Terminated
Class II FDA medical device recall by GE Healthcare, initiated 2013-12-12, terminated 2015-06-01. It names one FDA 510(k) clearance: K070247. 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..
- Recalling firm
- GE Healthcare
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-12-12
- Terminated
- 2015-06-01
- Firm location
- Laurel, MD, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 for recall
Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.
Data sourced from openFDA. This site is unofficial and independent of the FDA.