CME America BodyGuard Microset Infusion Sets Recalled for Delivery Inaccuracy
CME America is recalling BodyGuard Microset infusion administration 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 classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
CME America, LLC is recalling BodyGuard Microset infusion administration sets (REF: A120-161XPSV). The recall involves 291,386 units distributed across all 50 U.S. states, the District of Columbia, Canada, and the United Kingdom. The affected lots are all within their expiration dates.
The recall was initiated because the infusion administration sets may have a delivery inaccuracy exceeding plus or minus 13%, with reported ranges from minus 42.8% to plus 17.5%. This inaccuracy could result in the over-infusion or under-infusion of therapy when used with an infusion pump system.
Healthcare facilities and consumers who have these specific infusion sets should stop using them and contact CME America, LLC for instructions on return or replacement.
The recalled product
- Product
- BodyGuard Microset, REF: A120-161XPSV
- Manufacturer
- CME America, LLC
- Affected units
- 291,386
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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