CME America Recalls CMExpress Microbore Sets Due to Delivery Inaccuracy
CME America is recalling 13,280 CMExpress Microbore Sets because they may deliver fluids with significant inaccuracy, potentially causing 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 FDA Class I, which mandates a minimum severity score of 4 per the rubric, as Class I recalls represent a reasonable probability of serious adverse health consequences or death.
Plain-English summary
CME America, LLC is recalling 13,280 units of the CMExpress Microbore Set (REF: A120-160C). The recall covers all lots within their expiration dates. The product was distributed across 48 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 plus or minus 13%, with reported ranges from minus 42.8% to plus 17.5%. This inaccuracy could result in the over-infusion or under-infusion of therapy when used with an infusion pump system.
Healthcare facilities and consumers who possess these specific sets should stop using them immediately. CME America, LLC is the recalling firm responsible for managing the recall process.
The recalled product
- Product
- CMExpress Microbore Set, REF: A120-160C
- Manufacturer
- CME America, LLC
- Category
- Medical Device — Infusion Sets
- Affected units
- 13,280
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.
See all 37 products in this recall →Related recalls
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Same hazard · infusion inaccuracy
See all →- SevereCME America Recalls CMExpress Microbore Sets Due to Delivery Inaccuracy
FDA (Devices) · 2020-07-22
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