CME America BodyGuard Microset Infusion Sets Recalled for Delivery Inaccuracy
CME America is recalling BodyGuard Microset infusion sets because delivery inaccuracy could cause over-infusion 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 classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
CME America, LLC is recalling 5,000 units of BodyGuard Microset infusion administration sets, reference A120-160X2YB. The recall covers all lots within expiry.
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 affected products were distributed in the United States across 45 states and the District of Columbia, as well as in Canada and the United Kingdom. Consumers and healthcare providers should stop using the affected infusion sets and contact CME America, LLC for further instructions.
The recalled product
- Product
- BodyGuard Microset, REF: A120-160X2YB
- Manufacturer
- CME America, LLC
- Affected units
- 5,000
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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