CME 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- 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 severity score of at least 4 per the rubric. The hazard involves significant delivery inaccuracy that could lead to over- or under-infusion of therapy.
Plain-English summary
CME America, LLC is recalling 50 units of BodyGuard Microset With Female Luer (REF: A120-160XPSN). The recall covers all lots within the expiration date. 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 or minus 13 percent, with observed ranges from minus 42.8 percent to plus 17.5 percent. 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 possess these specific infusion sets should stop using them immediately. Users should contact CME America, LLC for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- BodyGuard Microset With Female Luer, REF: A120-160XPSN
- 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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