CME BodyGuard BodySet Infusion Sets Recalled for Delivery Inaccuracy
CME America is recalling BodyGuard BodySet infusion sets because they may deliver therapy at inaccurate rates, potentially causing over-infusion or under-infusion.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The recall is classified as FDA Class I, which meets the rubric criteria for a Critical severity score.
Plain-English summary
CME America, LLC is recalling 3,250 units of BodyGuard BodySet infusion administration sets (REF: A120-160SAS). The recall was initiated because the devices may have a delivery inaccuracy ranging from minus 42.8% to plus 17.5%, which exceeds the acceptable limit of plus/minus 13%.
The use of these infusion pump systems could result in the over-infusion or under-infusion of therapy. The affected units were distributed in 48 U.S. states, the District of Columbia, Canada, and the United Kingdom. All lots within the expiry date are included in this recall.
This is an FDA Class I recall. Healthcare facilities and consumers should stop using the affected infusion sets immediately and contact CME America for instructions on return or replacement.
The recalled product
- Product
- BodyGuard BodySet, REF: A120-160SAS
- Manufacturer
- CME America, LLC
- Category
- Medical Device — Infusion Sets
- Affected units
- 3,250
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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