Stand-Alone Resuscitation Unit, Bag and Mask, part number M1226444, labeled in part ***GE Healthc...
FDA Recall #Z-0914-2014 — Class II — December 12, 2013
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.
Recalling Firm
GE Healthcare — Laurel, MD
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
15 units
Distribution
Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Uruguay, Venezuela, Albania, Algeria, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Canada, Chile, China, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Kazakhstan, Korea, Kuwait, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates, and United Kingdom.
Code Information
Serial Numbers: QABS50026 QABR50066 QABR50068 QABR50133 QABS50023 QABR50102 QABR50103 QABR50064 QABR50065 QABR50067 QABS50070 QABS50069 QABR50275 QABS50027 QABR50274
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated