The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death
- GE Healthcare CareScape R860 Inspiratory Safety Guard
- Model/Item Numbers: 2066713-001 (single pack), 2083208-001 (box of ten single packs)
- Lot Numbers: 17/00951, 17/01174, 17/01937, 17/01994, 17/02372, 17/02393, 18/00126, 18/00127, 18/00128, 18/00129, 18/00130, 17/00951, 17/01174, 17/01937, 17/01994, 17/02372, 17/02393, 18/00126, 18/00127, 18/00128, 18/00129, 18/00130
- Manufacturing Dates: August 2017 to September 2018
- Distribution Dates: August 2017 to September 2018
- Devices Recalled in the U.S.: 307
GE Healthcare’s CareScape R860 Inspiratory Safety Guard is a breathing accessory designed for use with the Carescape R860 Ventilator. The Carescape R860 Ventilator provides mechanical ventilation and breathing support to infants, children, and adult patients. The Carescape R860 Ventilator and the CareScape R860 Inspiratory Safety Guard are designed for use only under a healthcare professional’s order within or during transport between medical facilities.
Reason for Recall
GE Healthcare is recalling the CareScape R860 Inspiratory Safety Guard due to the risk of the device disconnecting from the patient’s breathing circuit. As the result of a manufacturing defect, the safety guard’s outlet connector may have incorrect dimensions, which could result in the device not having a secure fit with the breathing circuit. This may result in the patient not receiving breathing support.
No patient injuries have been reported, although there remains a risk of ventilation and oxygen-loss (hypoxia) should the patient’s airway become disconnected from the breathing circuit.
Who May be Affected
- Hospitals and healthcare professionals using a Carescape R860 Ventilator with the CareScape R860 Inspiratory Safety Guard to provide patients with respiratory support.
- Patients receiving respiratory support from a Carescape R860 Ventilator with the CareScape R860 Inspiratory Safety Guard.
What to Do
On October 5, 2018, GE Healthcare sent customers an “Urgent Medical Device Recall Notification Letter”. The letter instructed customers to:
- Inspect all CareScape R860 Inspiratory Safety Guards in use.
- If the male connector slides freely up the entire length of the Inspiratory Safety Guard female port, this indicates an incorrect Inspiratory Safety Guard and an adapter will need to be used.
- If an adapter is not used, then the Inspiratory Safety Guard cannot be used.
- Complete and return the Customer Response Form enclosed with the firm’s recall notification letter if you do have affected Inspiratory Safety Guards.
- E-mail the completed form to Recall34095.InspiratorySG@ge.com
- Destroy or return all incorrect and affected unused Inspiratory Safety Guards remaining in their original packaging to GE Healthcare.
- Ensure all potential CareScape R860 Inspiratory Safety Guard users in your facility are aware of this safety notification and the recommended actions.
Customers who have questions or need additional information regarding this recall may contact your local Service Representative or contact GE Healthcare Customer Service at 1-800-437-1171.
Date Recall Initiated
October 5, 2018
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Health care professionals employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.