medical Class II Updated 2020-05-13

CME America, LLC recalls BodyGuard Microset For Use with the BodyGuard Infusion Pump

Recalled Product

BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage: The system is intended for patients who require maintenance medications, PCA therapy, parenteral nutritional fluids, and general IV fluid therapy in hospital and home care environments.

Hazard / Issue

The filter installed onto the tube set may have the incorrect pore size.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Product Name UDI Catalog No. Lot No. BodyGuard Microset 10818666020013 A120-160XSFK 90829 BodyGuard Microset 10818666020006 A120-112XSFK 16201
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