CME America Recalls CMExpress Microbore Sets Due to Delivery Inaccuracy
CME America is recalling CMExpress Microbore Sets because they may deliver therapy at inaccurate rates, potentially causing over-infusion or under-infusion.
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 FDA Class I, which mandates a severity score of at least 4 according to the rubric.
Plain-English summary
CME America, LLC is recalling the CMExpress Microbore Set, Reference A120-161CYF. The recall involves 25,286 units distributed across 49 U.S. states, the District of Columbia, Canada, and the United Kingdom.
The recall is being issued because the infusion administration sets may have a delivery inaccuracy exceeding plus or minus 13 percent, with observed ranges from minus 42.8 percent to plus 17.5 percent. The use of these sets with an infusion pump system could result in the over-infusion or under-infusion of therapy.
The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice. The agency classification for this recall is Class I.
The recalled product
- Product
- CMExpress Microbore Set, REF: A120-161CYF
- Manufacturer
- CME America, LLC
- Affected units
- 25,286
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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