Data Foundry

Medical device recalls 2020

BodyGuard Microset REF A120-003XYVA — Class I medical device recall Z-1442-2020

Terminated recall by CME America, LLC, reported 2020-03-18, distributed in CA, OH, PA, TX. When using a specific tubing set with infusion pump system, may result in under deliver of fluids.

Recall numberZ-1442-2020
Product typeMedical device
ClassificationClass I
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmCME America, LLC, Golden, CO, United States
Recall initiated2019-09-16
Classified2020-03-10
Reported by FDA2020-03-18
Terminated2022-04-13
DistributedCA, OH, PA, TX
Countries outside the USCA
Quantity69,400 infusion
UPC / GTIN / UDI-DI00818666020146
Lot numbers10636, 10653, 12117, 12836, 13156, 13279, 13656, 13978, 14057, 14188, 14545, 14790, 14966, 15073, 15277, 15434, 15802, 16173, 19486, 19490, 19492, 19834
Model numbersA120-003XYVA

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1442-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.