FDAClass IFebruary 20, 2013

GE Healthcare - Giraffe and Panda T-Piece Resuscitation recall

GE Healthcare - Giraffe and Panda T-Piece Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag…

Why was GE Healthcare - Giraffe and Panda T-Piece Resuscitation 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?

Models M1139417, M1223628, M1192226-072951, M1192226-084200. M1192226-095181, M1192226-104599

Product
GE Healthcare - Giraffe and Panda T-Piece Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag…
Recalling firm
GE Healthcare, LLC
Quantity
276 units total, 109 of those nationwide.
Distribution
Worldwide Distribution - Worldwide Distribution - USA including AL, AZ, CA, CO, FL,GA, IA, ID, IL, KY, MA, MD, MI, MN, MO, MS, MT, NC, ND ,NE, NM, NV, NY, OH, OR, PA ,TX, VT, WA, WI and WV; and the countries of Australia, Belgium, Canada, China, France, New Zealand, Poland, Saudi Arabia, Switzerland and United Kingdom.
Recall date
February 20, 2013
Classification
Class I
Status
Terminated
Agency
FDA (device)
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