Class I Recall of GE Healthcare's CareScape R860 Inspiratory Safety Guard
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. The U.S. Food and Drug Administration has classified this as a Class I Recall.
No patient injuries have been reported, although there remains a risk of hypoxia should the patient’s airway become disconnected from the breathing circuit.
Recalled Product(s) Details:
- 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
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.
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. Follow the link below for additional information.
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