CME America BodyGuard Microset Infusion Sets Recalled for Delivery Inaccuracy
CME America is recalling BodyGuard Microset infusion sets because they may deliver fluid at inaccurate rates, potentially causing over- 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 recall is classified as FDA Class I, which mandates a severity score of at least 4 per the rubric, due to the potential for serious health consequences from incorrect fluid delivery.
Plain-English summary
CME America, LLC is recalling BodyGuard Microset infusion administration sets with a 0.2 mic filter and lower y-site with female luer (REF: A120-160XYBF). The recall involves 6,016 units distributed across 48 U.S. states, the District of Columbia, Canada, and the United Kingdom.
The recall is due to a delivery inaccuracy in the infusion sets, which may range from minus 42.8% to plus 17.5%, exceeding the acceptable limit of plus/minus 13%. This inaccuracy could cause over-infusion or under-infusion of therapy when used with an infusion pump system.
Healthcare facilities and consumers should stop using the affected infusion sets and contact CME America for further instructions or a replacement.
The recalled product
- Product
- BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160XYBF
- Manufacturer
- CME America, LLC
- Category
- Medical Device — Infusion Sets
- Affected units
- 6,016
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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