CME America Recalls BodyGuard Microset Infusion Administration Sets
CME America is recalling BodyGuard Microset infusion administration 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 severity score of at least 4 per the rubric. The hazard involves significant delivery inaccuracies that could lead to over- or under-infusion of therapy.
Plain-English summary
CME America, LLC is recalling BodyGuard Microset infusion administration sets (REF: A120-161XYB). The recall involves 25,746 units distributed across 49 U.S. states, the District of Columbia, Canada, and the United Kingdom. All lots within the expiry date are affected.
The recall was initiated because the infusion administration sets may have a delivery inaccuracy ranging from minus 42.8% to plus 17.5%, which exceeds the acceptable limit of plus/minus 13%. 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 products should stop using them and contact CME America, LLC for further instructions on return or replacement.
The recalled product
- Product
- BodyGuard Microset, REF: A120-161XYB
- Manufacturer
- CME America, LLC
- Affected units
- 25,746
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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