CME America Recalls Infusion Sets Due to Delivery Inaccuracy
CME America is recalling Standard BodySet infusion sets because they may deliver therapy at inaccurate rates, potentially causing over- or under-infusion.
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 agency classified this as a Class I recall, which mandates a severity score of at least 4 per the rubric, as the defect poses a reasonable probability of serious adverse health consequences.
Plain-English summary
CME America, LLC is recalling Standard BodySet with Needleless Connectors (REF: A120-125XS) due to a defect in the infusion administration sets. The affected products may have a delivery inaccuracy exceeding plus or minus 13%, with observed ranges from minus 42.8% to plus 17.5%.
The recall covers 36,286 units distributed across 48 U.S. states and the District of Columbia, as well as Canada and the United Kingdom. All lots within the expiry date are affected. The use of these infusion pump systems could result in the 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 on the recall.
The recalled product
- Product
- Standard BodySet with Needleless Connectors, REF: A120-125XS
- Manufacturer
- CME America, LLC
- Affected units
- 36,286
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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