CME America BodyGuard Microset Infusion Sets Recalled for Delivery Inaccuracy
CME America is recalling BodyGuard Microset infusion administration sets because they may deliver therapy with significant inaccuracy, potentially causing over-infusion or under-infusion.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a significant delivery inaccuracy that poses a risk of harm (over-infusion or under-infusion), but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
CME America, LLC is recalling BodyGuard Microset infusion administration sets (REF: A100-163XES). The recall involves 140,565 units of the product. The sets are distributed across all 50 U.S. states, the District of Columbia, Canada, and the United Kingdom.
The recall is due to a delivery inaccuracy in the infusion administration sets. The inaccuracy ranges from minus 42.8% to plus 17.5%, which exceeds the acceptable limit of plus/minus 13%. This defect means the infusion pump system may not deliver the intended volume of therapy.
Use of the affected 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: A100-163XES
- Manufacturer
- CME America, LLC
- Affected units
- 140,565
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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