Home / Recalls / CME America, LLC / Z-1442-2020

Z-1442-2020 Class I Terminated

Recalled by CME America, LLC — Golden, CO

Recall Details

Product Type
Devices
Report Date
March 18, 2020
Initiation Date
September 16, 2019
Termination Date
April 13, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
69400 infusion sets

Product Description

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 Pattern

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

Code Information

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

Other recalls by CME America, LLC

  • Z-0530-2021 Class II — CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or flu (July 30, 2020)
  • Z-0526-2021 Class II — CME America T-Syringe Pump - NeoThrive - Product Usage: infusion of medications (July 30, 2020)
  • Z-0525-2021 Class II — CME America T-Syringe Pump -T34L - Product Usage: infusion of medications or flu (July 30, 2020)
  • Z-0528-2021 Class II — CME America T-Syringe Pump - Neofeed - Product Usage: infusion of medications or (July 30, 2020)
  • Z-0529-2021 Class II — CME America T-Syringe Pump - Ameritus 1st Enteral Pump - Product Usage: infusion (July 30, 2020)
  • Z-0527-2021 Class II — CME America T-Syringe Pump - T34L PCA - Product Usage: infusion of medications o (July 30, 2020)
  • Z-2575-2020 Class I — BodyGuard Microset, REF: A120-003XS2YV (June 16, 2020)
  • Z-2588-2020 Class I — BodyGuard Microset With Female Luer, REF: A120-160XPSN (June 16, 2020)
  • Z-2571-2020 Class I — BodyGuard Microset with Filter, REF: A120-160XSFE (June 16, 2020)
  • Z-2562-2020 Class I — BodyGuard Microset, REF: A120-161XYB (June 16, 2020)