FDAJanuary 7, 2020device

CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpress

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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)

What to do

FDA enforcement status: Terminated

Brands named

cme americacme

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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