CME America Recalls BodyGuard Microset Infusion Sets Due to Delivery Inaccuracy
CME America is recalling BodyGuard Microset infusion sets because they may deliver therapy with significant inaccuracy, potentially causing over- 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 source text identifies a significant functional defect in a medical device that could cause over-infusion or under-infusion of therapy, which aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk device defects, warranting a Severe rating.
Plain-English summary
CME America, LLC is recalling BodyGuard Microset infusion administration sets, reference number A120-125XSE. The recall involves 31,484 units. The product was distributed across 48 U.S. states and the District of Columbia, as well as Canada and the United Kingdom.
The recall is being issued because the infusion administration sets may have a delivery inaccuracy exceeding plus or minus 13%, with observed ranges from minus 42.8% to plus 17.5%. The use of these infusion pump systems could result in the over-infusion or under-infusion of therapy.
Healthcare facilities and consumers who have these specific infusion sets should stop using them and contact CME America, LLC for further instructions on the recall process.
The recalled product
- Product
- BodyGuard Microset, REF: A120-125XSE
- Manufacturer
- CME America, LLC
- Category
- Medical Device — Infusion Pumps
- Affected units
- 31,484
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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