Reported Mar 25, 2020 · Terminated
CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and…
CME America, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CME America, LLC · 14998 W 6th Ave Ste 830 · Golden, CO · 80401-5025
Is this the product you have?
CME America BodyGuard Infusion Pump SystemAll models of BG 323BG 121BG 545BG CV545BG 575BG CV575and CMExpress
- Lot codes and dates
- All serial numbers
- Amount recalled
- 30,596 pumps
Where it was sold
Why it was recalled
Stop using this product now
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)
Using this product could cause serious injury, illness or death — stop using it now.
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