CME America BodyGuard Microset Infusion Sets Recalled for Delivery Inaccuracy
CME America is recalling BodyGuard Microset infusion sets because they may deliver therapy with significant inaccuracy, 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 classified this as a Class I recall, which mandates a severity score of at least 4 per the rubric. The hazard involves significant delivery inaccuracy in a medical device that could lead to over-infusion or under-infusion of therapy.
Plain-English summary
CME America, LLC is recalling 50 units of BodyGuard Microset infusion administration sets (REF: A120-160XYSF). The recall covers all lots within expiry. The product was distributed to 49 states, the District of Columbia, Canada, and the United Kingdom.
The recall was initiated because the infusion administration sets may have a delivery inaccuracy exceeding plus/minus 13%, with a range from minus 42.8% to plus 17.5%. The use of the infusion pump system could cause 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.
The recalled product
- Product
- BodyGuard Microset, REF: A120-160XYSF
- Manufacturer
- CME America, LLC
- Affected units
- 50
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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