CME America BodyGuard Microset Infusion Sets Recalled for Delivery Inaccuracy
CME America is recalling BodyGuard Microset infusion sets because they may deliver therapy at inaccurate rates, potentially causing over-infusion or under-infusion.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric, as the device defect poses a risk of serious injury through incorrect therapy delivery.
Plain-English summary
CME America, LLC is recalling BodyGuard Microset with Filter (REF: A100-164XESF) infusion administration sets. The recall involves 55,455 units distributed across the United States and in Canada and the UK.
The recall is due to a delivery inaccuracy in the infusion sets, which may range from minus 42.8% to plus 17.5% (over plus/minus 13%). The use of these infusion pump systems could cause over-infusion or under-infusion of therapy.
Healthcare facilities and consumers who have these products should stop using them and contact CME America, LLC for instructions on return or replacement.
The recalled product
- Product
- BodyGuard Microset with Filter, REF: A100-164XESF
- Manufacturer
- CME America, LLC
- Affected units
- 55,455
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots within expiry
Distribution
Part of a larger recall action
This product is one of 37 recalled by CME America, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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