Recall Z-0606-2013— GE Healthcare, LLC

Name: FDA recall Z-0606-2013
Creator: U.S. Food and Drug Administration
Published: 2012-06-26

Class I · Terminated

Class I FDA medical device recall by GE Healthcare, LLC, initiated 2012-06-26, terminated 2014-04-14. It names one FDA 510(k) clearance: K070210. 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.. 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..

Recalling firm: GE Healthcare, LLC
Classification: Class I
Status: Terminated
Initiated: 2012-06-26
Terminated: 2014-04-14
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K070210 — GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEMOhmeda Medical·cleared 2007-04-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.