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Stand-Alone Resuscitation Unit, Bag and Mask, Upgrade Kits, part number M1139612, labeled in part...

FDA Recall #Z-0915-2014 — Class II — December 12, 2013

Recall #Z-0915-2014 Date: December 12, 2013 Classification: Class II Status: Terminated

Product Description

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 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

48 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: 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

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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