GE Healthcare, LLC recalls GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable with Size 1

Recalled January 2, 2013 · FDA recall Z-0606-2013 · GE Healthcare

Hazard

Disposable T-Piece circuits used with resuscitation systems are unable to achieve maximum Peak Inspiratory Pressure (PIP) during the pre-use check out procedure. · FDA Class I

Units

209,804 circuits

Sold at

Worldwide Distribution - USA, including DC and the states of AL, AK, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IN, IL, KY, KS, LA, MA, MD, ME, MI, MN, MO,MS, MT, NC, NE, NJ, NM, NY, NV, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of Albania, Australia, Austria, Bahrain, Bangladesh, Belgium, Canada, China, Czech Rep., Egypt, Finland, France, Germany, Great Britain, Greece, India, Indonesia, Ireland, Israel, Italy, Jordan, Kazakhstan, S. Korea, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, and Arab Emirates,

Description

Disposable T-Piece circuits used with resuscitation systems are unable to achieve maximum Peak Inspiratory Pressure (PIP) during the pre-use check out procedure.

Product

GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 Mask***M1091335 QTY: 10 T-Piece Disposable Circuit, QTY: 10, M1091316 T-Piece Disposable Circuit Kit with Mask Size O; M1091365 QTY: 10 T-Piece Disposable Circuit Kit with Mask, Size 1, Lot 1981713 *** Ohmeda Medical, A Division of Datex-Ohmeda, Inc. A General Electric Company Laurel, MD 20723 USA MADE IN USA*** 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 →