CME America Recalls CMExpress Needleless Y Site Microbore Sets
CME America is recalling 1,824 CMExpress Needleless Y Site Microbore Sets due to delivery inaccuracy that could 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 agency classification is Class I, and the rubric states that if the agency's own classification is FDA Class I, the score must never go below 4. The defect poses a risk of significant harm through incorrect therapy delivery.
Plain-English summary
CME America, LLC is recalling 1,824 units of the CMExpress Needleless Y Site Microbore Set, reference number A120-160CYNVK. The recall covers all lots within the expiration date. The product was distributed to facilities in 47 U.S. states, the District of Columbia, Canada, and the United Kingdom.
The recall was initiated because the infusion administration sets may have a delivery inaccuracy exceeding the acceptable range of plus or minus 13 percent. The source text notes that the inaccuracy ranges from minus 42.8 percent to plus 17.5 percent. This defect could cause over-infusion or under-infusion of therapy when used with an infusion pump system.
Healthcare facilities and consumers who have this product should stop using it immediately. CME America, LLC is the recalling firm responsible for the recall.
The recalled product
- Product
- CMExpress Needleless Y Site Microbore Set, REF: A120-160CYNVK
- Manufacturer
- CME America, LLC
- Affected units
- 1,824
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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