CME America BodyGuard Infusion Sets Recalled for Delivery Inaccuracy
CME America is recalling BodyGuard infusion sets because they may deliver therapy at inaccurate rates, 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 defect 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 7,200 units of BodyGuard set with Female Luer, REF: A120-003XSN. The recall covers all lots within expiry. The product was distributed to 49 U.S. states and the District of Columbia, as well as Canada and the UK.
The recall is due to a defect where the infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. The source text notes that use of the infusion pump system could cause over-infusion or under-infusion of therapy.
Healthcare facilities and consumers should stop using the affected BodyGuard sets and contact CME America, LLC for further instructions or a return.
The recalled product
- Product
- BodyGuard set with Female Luer, REF: A120-003XSN
- Manufacturer
- CME America, LLC
- Affected units
- 7,200
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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