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