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U.S. Department of Health and Human Services

Safety

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GE Healthcare T-Piece Circuits for the Giraffe and Panda Resuscitation Systems: Class I Recall – Failure to Achieve the Desired Inspiratory Pressure During Ventilation

 

[Posted 12/28/2012]

AUDIENCE: Emergency Medicine, Pediatrics, Risk Manager

ISSUE: The disposable T-piece circuits do not achieve the maximum positive inspiratory pressure (PIP) levels of 45 +/- 5 cmH2O needed for intense resuscitation. This failure to achieve the desired inspiratory pressure during ventilation may result in inadequate therapy, and the need for additional medical intervention. This product may cause serious adverse health consequences, including death. 

BACKGROUND: The T-Piece Resuscitation System is used for the pulmonary resuscitation of infants.

RECOMMENDATION: Customers who have purchased the affected devices were notified by letter with a return receipt dated July 12, 2012. All customers should inspect their stock of T-piece circuits and destroy all circuits with a red inspection stamp. T-pieces with a blue inspection stamp are safe for use.

The recall notice recommends that clinicians do not use a T-piece patient circuit that does not reach the maximum PIP level of 45 +/- 5 cmH2O and always use the built-in Airway Pressure Manometer to verify the PIP value. Healthcare processionals should also continue to emphasize the recommended pre-use checkout practices.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[12/28/2012 - Recall Notice - FDA]
[12/26/2012 - Firm Press Release - GE Healthcare]