FDA-Device2020-05-13Class II
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.
CME America, LLC
Hazard
The filter installed onto the tube set may have the incorrect pore size.
Sold states
US Nationwide distribution including in the states of AK, CA, IL, KS, MA, MO, and SD. No O.U.S.
Affected count
5,800 infusion sets from lot 90829 and 24,500 from lot 16201
Manufactured in
14998 W 6th Ave Ste 830, N/A, Golden, CO, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1886-2020Don't want to check this manually?
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