GE Healthcare, LLC recalls Giraffe and Panda Bag and Mask Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered r

Recalled February 20, 2013 · FDA recall Z-0749-2013 · GE Healthcare

Hazard

Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly. · FDA Class I

Units

276 units total, 109 of those nationwide.

Sold at

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.

Description

Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.

Product

Giraffe and Panda Bag and Mask Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants.

Manufacturer(s)

GE Healthcare, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →