—#125030

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.

FDA product code: BTM — Ventilator, Emergency, Manual (Resuscitator)
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K070247
Affected lot / code info: Serial Numbers: QABS50026 QABR50066 QABR50068 QABR50133 QABS50023 QABR50102 QABR50103 QABR50064 QABR50065 QABR50067 QABS50070 QABS50069 QABR50275 QABS50027 QABR50274

Why it was recalled

Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.

Root cause (FDA determination)

Process control

Action the firm took

GE Healthcare notified end users with a letter flagged as Urgent Medical Device Correction letter on 12/12/2013. The notification advised that GE Healthcare has become aware of a potential safety issue associated with the loosening of the blender knob shaft on all Resuscitation units. The firm advised that accounts ensure that all potential users in their facility are made aware of this safety notification and the recommended actions described in the notification: 1. Perform blender accuracy check as outlined in Section 2.5-2.5.1 of the Service Manual to verify that the O2 concentration set at 21% is within 16-26% O2 and the concentration at 100% setting is within the recommended range (95-105% O2). 2. If the blender accuracy test results do not meet specifications, remove the unit from patient use and contact a GE Healthcare Service Representative at the number listed below. 3. If the blender accuracy check passes in Step 1 above, you may continue to use your resuscitation system. The following precautions are recommended to ensure blender accuracy is maintained between system checks. Use an independent oxygen analyzer, as determined by your hospital policy, to check blended Air/O2 accuracy. When delivering Oxygen, use a pulse oximeter to monitor your patient. Customers were requested to contact a GE Healthcare Service Representative at 1-800-345-2700 to arrange for correction if the device is found to be defective.

Recalling firm

Firm: GE Healthcare
Address: 8880 Gorman Rd, Laurel, Maryland 20723-5800

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2013-12-12
Posted by FDA: 2014-02-03
Terminated: 2015-06-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #125030. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.