CME America Recalls BodyGuard Microset Infusion Sets Due to Delivery Inaccuracy
CME America is recalling BodyGuard Microset infusion sets because they may deliver therapy at inaccurate rates, potentially causing over-infusion or under-infusion.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that the device defect could cause over-infusion or under-infusion of therapy, which constitutes a significant injury risk for patients receiving medical treatment.
Plain-English summary
CME America, LLC is recalling 16,850 units of BodyGuard Microset with Filter (REF: A120-160XSFE) infusion administration sets. The recall covers all lots within expiry. The product was distributed to 49 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/minus 13%, with reported ranges from minus 42.8% to plus 17.5%. The use of these infusion pump systems could result in the 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 with Filter, REF: A120-160XSFE
- Manufacturer
- CME America, LLC
- Affected units
- 16,850
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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