Class I Medical Device Recall: GE Healthcare, LLC, Giraffe and Panda T-Piece Resuscitation Systems, and the Giraffe and Panda Bag and Mask Resuscitation Systems
Recall Class: Class I
Date Recall Initiated: October 15, 2012
Products: GE Healthcare, Inc., Giraffe and Panda T-Piece Resuscitation Systems, and the Giraffe and Panda Bag and Mask Resuscitation Systems
Trade Names: Giraffe and Panda Warmer T-Piece Resuscitation System
Giraffe and Panda Bag and Mask Resuscitation System
These products were manufactured and distributed from April 1, 2008 through September 30, 2012.
Use: The Giraffe and Panda T-Piece Resuscitation Systems and the Giraffe Panda Bag and Mask Resuscitation Systems provide the basic equipment required for pulmonary resuscitation of infants.
GE Healthcare, LLC
3000 North Grand View Boulevard
Mail Box: Mail Stop W450
Waukesha, Wisconsin 53188-1615
Reason for Recall: The oxygen and air wall inlet fittings and/or labels on the back panel of the resuscitation systems may have been reversed during assembly. As a result, this could potentially reverse the air/oxygen concentrations; for example, a setting of 100% oxygen could have an output of 21% oxygen and vice versa. The settings of the blender knob would no longer be accurate.
This product may cause serious adverse health consequences, including death.
Public Contact: Customers with questions may contact the firm at 1-800-345-2700. For questions about this recall, call 262-513-4122.
FDA District: Baltimore
On October 15, 2012, GE Healthcare sent its affected customers an "Urgent Medical Device Correction" letter with a return receipt. The letter identified the product, the problem, and the action to be taken by the customer along with the product correction.
Required Action for Users:
- It is recommended that a qualified biomedical technician or respiratory therapist identify the affected resuscitation system and locate the air and oxygen fittings and labels at the back of the unit. With the table provided, identify the appropriate fitting for their country and location and verify the air fitting is located on the left side and the oxygen fitting is located on the right.
- Verify the air label is located on the left side and the oxygen label is on the right. Verify that the color of the air and oxygen labels match the picture on the table provided.
- If the unit does not meet all of the criteria, the unit will require repair.
- If the unit is in use with the patient, disconnect the wall supply gas and switch to a tank supply. Once the patient no longer requires respiratory support, transfer the patient to another bed and remove the unit from service. A Field Engineer will be deployed to your site to complete the required repair.
- If the unit is NOT in use with the patient, take the unit out of service. A Field Engineer will be deployed to your site to complete the required repair.
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.