device · product 1 of 1
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.
- Recall number
- Z-0606-2013
- Initiated
- June 26, 2012
- Classification
- Class I
- Status
- Terminated
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 209,804 circuits
App-derived interpretation
Disposable T-Piece circuits used with resuscitation systems are unable to achieve maximum Peak Inspiratory Pressure (PIP) during the pre-use check out procedure.
Official device-enrichment evidence · Sourced
Nonconforming Material/Component
Inspect official wording and provenance
Reason for recall
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,