FDA recall Z-1442-2020

Product

BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: The BodyGuard Infusion Pump System is designed to transfer medication and fluids intravenously.

Reason for recall

When using a specific tubing set with infusion pump system, may result in under deliver of fluids.

Distribution

US: CA, OH, PA, and TX OUS: Canada

Key facts

Status

Terminated

Initiation date

2019-09-16

Report date

2020-03-18

Termination date

2022-04-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Golden, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1442-2020