CME America Recalls BodyGuard Microset Infusion Administration Sets
CME America is recalling BodyGuard Microset infusion administration sets due to delivery inaccuracy that could cause over-infusion or under-infusion of therapy.
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 agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.
Plain-English summary
CME America, LLC is recalling 146 units of BodyGuard Microset infusion administration sets (REF: A100-163XSFL). The recall covers all lots within expiry. The product was distributed to facilities in 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.
Healthcare facilities and consumers should stop using the affected BodyGuard Microset infusion administration sets and contact CME America, LLC for further instructions.
The recalled product
- Product
- BodyGuard Microset, REF: A100-163XSFL
- Manufacturer
- CME America, LLC
- Category
- Medical Device — Infusion Pumps
- Affected units
- 146
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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