CME America Recalls BodyGuard Microset Infusion Sets Due to Delivery Inaccuracy
CME America, LLC is recalling BodyGuard Microset infusion sets because they may deliver therapy with significant inaccuracy, potentially causing over-infusion or under-infusion.
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'. Per the rubric, FDA Class I recalls are assigned a score of 5 (Critical) because they are reasonable probabilities of causing serious adverse health consequences or death.
Plain-English summary
CME America, LLC is recalling BodyGuard Microset with Needleless Adaptor (REF: A120-003XSNY) due to a defect in the infusion administration sets. The recall involves 198,160 units distributed across all 50 U.S. states, the District of Columbia, Canada, and the United Kingdom.
The FDA has classified this as a Class I recall. The source text states that the infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. This inaccuracy means that use of the infusion pump system could cause over-infusion or under-infusion of therapy.
Healthcare facilities and consumers who have these products should stop using them and contact CME America, LLC for instructions on return or replacement. The recall covers all lots within expiry.
The recalled product
- Product
- BodyGuard Microset with Needleless Adaptor, REF: A120-003XSNY
- Manufacturer
- CME America, LLC
- Affected units
- 198,160
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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