GE Healthcare - Giraffe and Panda Bag and Mask recall
GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe Stand-alone Infant Resuscitation System. Product Usage: The Bag and Mask…
Why was GE Healthcare - Giraffe and Panda Bag and Mask recalled?
Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
QABS50026, QABR50066, QABR50068, QABR50133, QABS50023, QABR50102, QABR50103, QABR50064, QABR50065, QABR50067, QABS50070, QABS50069, QABR50275, QABS50027, QABR50274
- Product
- GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe Stand-alone Infant Resuscitation System. Product Usage: The Bag and Mask…
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 12, 373 units total, 8,807 = US, 3,394 = OUS, 172 = unknown
- Distribution
- Worldwide Distribution - USA Nationwide including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL,GA. HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and the countries of Albania, Austria, Australia, Bahrain, Belarus, Belgium, Canada, China, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Greece, Guatemala, Germany, Honduras, Hong Kong, Hungry, India, Indonesia, Ireland, Italy, Kazakhstan, Korea, Lithuania, Malaysia, Mexico, Netherlands, Norway, Peru, Poland, Romania, Russia, Saudi Arabia, South Africia, Spain, Sweden, Switzerland Turkey, United Arab, United Kingdom, and Venezuela.
- Recall date
- March 5, 2014
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)