CME BodyGuard Microset Infusion Sets Recalled for Delivery Inaccuracy
CME America is recalling BodyGuard Microset infusion sets due to delivery inaccuracies that may cause 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, as it involves a reasonable probability of serious adverse health consequences or death due to significant delivery inaccuracies.
Plain-English summary
CME America, LLC is recalling BodyGuard Microset infusion administration sets (REF: A100-163XESV). The recall involves 178,057 units distributed across all 50 U.S. states, the District of Columbia, Canada, and the United Kingdom.
The recall is issued because the infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. The use of the infusion pump system could cause over-infusion or under-infusion of therapy.
Healthcare facilities and consumers should stop using the affected infusion sets and contact CME America, LLC for further instructions or a replacement.
The recalled product
- Product
- BodyGuard Microset, REF: A100-163XESV
- Manufacturer
- CME America, LLC
- Affected units
- 178,057
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 date
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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