CME BodyGuard Microset Infusion Sets Recalled for Delivery Inaccuracy
CME America is recalling BodyGuard Microset infusion sets due to potential delivery inaccuracies that could cause over- or under-infusion of therapy.
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.
Plain-English summary
CME America, LLC is recalling BodyGuard Microset infusion administration sets with a 0.2 mic filter and lower y-site with female luer (REF: A120-160CYFRV). The recall involves 152,570 units distributed across 48 U.S. 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%, with observed ranges from minus 42.8% to plus 17.5%. The use of these infusion pump systems could result in 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 return or replacement.
The recalled product
- Product
- BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160CYFRV
- Manufacturer
- CME America, LLC
- Affected units
- 152,570
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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