Company: CME America, LLC
Date of Enforcement Report: 3/25/2020
Class I

PRODUCT

CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG CV545, BG CV575, and CMExpress

• Recall Number: Z-1474-2020

REASON

Infusion Pump Systems may have a delivery inaccuracy of up to 13%, which may result in 1) faster than expected drug delivery when infusing at a very low rate (0.1 mL/h), or 2) slower than expected drug delivery when infusing at high flow rates (greater-than 500 mL/h)

RECALLING FIRM/MANUFACTURER

CME America, LLC on 1/7/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

28448

DISTRIBUTION

US Nationwide