RecallRadar

FDA Device recall Z-1886-2020

BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage: The system is inten…

On 2020-05-13 the FDA classified a Class II recall of BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage: The system is inten… by Cme America, citing the filter installed onto the tube set may have the incorrect pore size.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1886-2020
ClassificationClass II
Statusterminated
Initiated2020-01-14
Published2020-05-13
Last updated2026-09-13 11:55 UTC
CompanyCme America
DistributionUS

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

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

Identifiers

code_info
Product Name UDI Catalog No. Lot No. BodyGuard Microset 108186660…Product Name UDI Catalog No. Lot No. BodyGuard Microset 10818666020013 A120-160XSFK 90829 BodyGuard Microset 10818666020006 A120-112XSFK 16201

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-1886-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.