CME BodyGuard Microset Infusion Sets Recalled for Delivery Inaccuracy
CME America is recalling BodyGuard Microset infusion sets due to delivery inaccuracies that may 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 classified this as a Class I recall, which mandates a minimum severity score of 4 per the rubric. The hazard involves significant delivery inaccuracies in medical devices that could lead to serious patient harm through incorrect therapy administration.
Plain-English summary
CME America, LLC is recalling BodyGuard Microset with Filter (REF: A100-163XESF) infusion administration sets. The recall involves 95,110 units distributed across all 50 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 over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system with these sets could cause over-infusion or under-infusion of therapy.
Healthcare facilities and consumers should stop using the affected infusion sets and contact CME America, LLC for further instructions or replacement.
The recalled product
- Product
- BodyGuard Microset with Filter, REF: A100-163XESF
- Manufacturer
- CME America, LLC
- Affected units
- 95,110
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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