CME America Recalls CMExpress Microbore Sets Due to Delivery Inaccuracy
CME America is recalling CMExpress Microbore Sets because they may deliver fluids with significant inaccuracy, potentially causing 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 classified this as a Class I recall, and the rubric mandates a score of at least 4 for FDA Class I recalls. Additionally, the potential for significant injury due to over- or under-infusion of therapy supports a Severe rating.
Plain-English summary
CME America, LLC is recalling 113,482 units of CMExpress Microbore Sets, REF: A120-160CYFRV. The recall was initiated because the infusion administration sets may have a delivery inaccuracy exceeding plus or minus 13%, with observed ranges from minus 42.8% to plus 17.5%.
The use of these infusion pump systems could result in the over-infusion or under-infusion of medical therapy. The affected units were distributed across all 50 U.S. states, the District of Columbia, Canada, and the United Kingdom.
Healthcare facilities and consumers should stop using the affected infusion sets immediately. CME America, LLC is the recalling firm responsible for managing this safety action.
The recalled product
- Product
- CMExpress Microbore Sets, REF: A120-160CYFRV
- Manufacturer
- CME America, LLC
- Category
- Medical Device — Infusion Sets
- Affected units
- 113,482
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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Same hazard · infusion inaccuracy
See all →- SevereCME America Recalls CMExpress Microbore Sets Due to Delivery Inaccuracy
FDA (Devices) · 2020-07-22