CME America BodyGuard Microset Infusion Sets Recalled for Delivery Inaccuracy
CME America is recalling BodyGuard Microset infusion administration sets due to delivery inaccuracy that may cause over-infusion or under-infusion of therapy.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly identifies the agency classification as Class I, which mandates a severity score of 5 (Critical) according to the rubric.
Plain-English summary
CME America, LLC is recalling BodyGuard Microset infusion administration sets (REF: A120-112XSFK). The recall involves 1,273,892 units. The product was distributed to 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 over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy.
The agency classifies this as a Class I recall. Healthcare providers and consumers should stop using the affected products and contact the manufacturer for further instructions.
The recalled product
- Product
- BodyGuard Microset, REF: A120-112XSFK
- Manufacturer
- CME America, LLC
- Affected units
- 1,273,892
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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