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CME America, LLC recalls BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage:
Recalled May 13, 2020 · FDA recall Z-1886-2020 · CME America
Hazard
The filter installed onto the tube set may have the incorrect pore size. · FDA Class II
Units
5,800 infusion sets from lot 90829 and 24,500 from lot 16201
Sold at
US Nationwide distribution including in the states of AK, CA, IL, KS, MA, MO, and SD. No O.U.S.
Description
The filter installed onto the tube set may have the incorrect pore size.
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.
Manufacturer(s)
CME America, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →