Recall notification - CMEAmerica BodyGuard® Microset

Sep 16, 2019

CME America is conducting a voluntary medical device recall for all lots of CMEAmerica BodyGuard® Microset, Catalog #A120-003XYVA.

When used with the BodyGuard Infusion Pump System the delivery accuracy specification is ±5%. Investigation indicates that the A120-003XYVA tube set may under deliver fluid. The tube set will underdeliver up to 50% at the highest flow rates (>500 ml/hr). Inadequate delivery of fluid can be detected when there is unexpected fluid remaining in the reservoir.

The BodyGuard Infusion Pump System are typically indicated for chemotherapy, TPN, pain management and antibiotics. The device is not indicated for the infusion of blood, blood products. There have been no reports to date of adverse event or injury.

If you require further assistance, please contact Customer/Technical Support at 303-936-4545 or 877-263-0111 toll free.


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