CME America, LLC: Medical Device Recall in 2020 - (Recall #: Z-1886-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 14, 2020

Date Posted: May 13, 2020

Recall Number: Z-1886-2020

Event ID: 85206

Reason for Recall:

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

Status: Terminated

Product Quantity: 5,800 infusion sets from lot 90829 and 24,500 from lot 16201

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated