The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2587-2020·Announced 2020-07-22

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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Category
Medical Device — Infusion Administration Set
Hazard
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

Distributed in 49 states:

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.

See all 37 products in this recall →

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