RecallRadar

FDA Device recall Z-1442-2020

BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: The BodyGuard Infusion Pum…

On 2020-03-18 the FDA classified a Class I recall of BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: The BodyGuard Infusion Pum… by Cme America, citing when using a specific tubing set with infusion pump system, may result in under deliver of fluids.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1442-2020
ClassificationClass I
Statusterminated
Initiated2019-09-16
Published2020-03-18
Last updated2026-09-13 11:55 UTC
CompanyCme America
DistributionCA, OH, PA, TX

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

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

Identifiers

code_info
Catalog Number: A120-003XYVA UDI: 00818666020146 Lot Numbers: 10636 10653 12117 12836 13156 13279 13656 1…Catalog Number: A120-003XYVA UDI: 00818666020146 Lot Numbers: 10636 10653 12117 12836 13156 13279 13656 13978 14057 14188 14545 14790 14966 15073 19486 19490 19492 19834 16173 14966 15073 15277 15434 15802

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1442-2020%22

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