Class I Medical Device Recall: GE Healthcare T-Piece Circuits for the Giraffe and Panda Resuscitation Systems
Recall Class: Class I
Date Recall Initiated: June 13, 2012
- T-Piece Circuits for the Giraffe Resuscitation Systems
- T-Piece Circuits for the Panda Resuscitation Systems
Model/catalog/lot numbers: All lots manufactured between September 01, 2009 and May 01, 2012.
- T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 Mask: M1091335, 10 Pack
- T-Piece Neonatal Patient Circuit Kit Disposable with Size 0 Mask: M1091316, 10 Pack
- T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 Mask: M1091365, 10 Pack
Manufacturing and Distribution Dates: The affected products were manufactured and distributed from September 01, 2009 to May 01, 2012.
Use: The T-Piece Resuscitation System is used for the pulmonary resuscitation of infants.
GE Healthcare, LLC.
3000 N. Grandview Blvd.
Waukesha, Wisconsin 53188-1615
Reason for Recall: The disposable T-piece circuits do not achieve the maximum positive inspiratory pressure (PIP) levels of 45 +/- 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.
Public Contact: Customers with the device should contact 1-800-345-2700 or for more information.
FDA District: Baltimore District Office
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. Customers should also fill out the customer acknowledgement form included in the recall notice and fax or mail it to the address on the form.
The recall notice recommends that clinicians do not use a T-piece patient circuit that does not reach the maximum PIP level of 45 +/- 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.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.