FDA recall Z-1886-2020

CME America, LLC · Class II · device

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.

Reason for recall

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

Distribution

US Nationwide distribution including in the states of AK, CA, IL, KS, MA, MO, and SD. No O.U.S.

Key facts

Status
Terminated
Initiation date
2020-01-14
Report date
2020-05-13
Termination date
2021-05-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Golden, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1886-2020