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Recall Observatory FDA recall evidence

Device 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.

Z-0606-2013

June 26, 2012

Class I

Product summary

Firm
GE Healthcare, LLC
Event
Event 63123
Status
Terminated
Classification
Class I
Quantity
209,804 circuits
Official record key
device-enforcement:Z-0606-2013

Official wording

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

Code information: 7742443, 7785387, 7860461, 7875369, 7909560, and 8145199.

Distribution pattern: 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,

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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