CME America recalls BodyGuard infusion pumps (BG 323, BG 121, etc.) due to potential 13% delivery inaccuracy at low/high flow rates. Affected units may deliver drugs too fast or too slow, risking treatment errors.
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)
CME America is recalling several models of BodyGuard infusion pumps because they may deliver medication up to 13% faster or slower than intended. This could cause serious treatment errors if the pump is used for critical medications.
The pumps may deliver medication too quickly at very low rates (0.1 mL/h) or too slowly at high rates (over 500 mL/h), causing treatment errors. This inaccuracy could lead to harmful medication levels.
People using these infusion pumps for medical treatments are affected. Those with critical medications requiring precise dosing are at higher risk.
Check for the product names BG 323, BG 121, BG 545, BG CV545, BG 575, or BG CV575. All units have serial numbers listed in the recall notice.
Look for the serial number on the pump to confirm if it's affected by this recall.
Reach out to CME America for guidance on next steps if you have an affected pump.
The pumps may deliver medication up to 13% faster or slower than intended, which could cause treatment errors.
BG 323, BG 121, BG 545, BG CV545, BG 575, and BG CV575 models.
No, but you should check the serial number and contact CME America for guidance.
We’ve drafted a message you can send CME America to request your refund or repair — edit it as you like.
Subject: Recall Z-1474-2020 — CME America CME America Hello, I own a CME America that is covered by recall Z-1474-2020 from CME America. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
