CME America Recalls CMExpress Microbore Sets Due to Delivery Inaccuracy
CME America, LLC is recalling CMExpress Microbore Sets because they may deliver fluids with significant inaccuracy, potentially causing over-infusion 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, which mandates a minimum score of 4. The hazard involves significant delivery inaccuracy that could lead to over-infusion or under-infusion of therapy, representing a risk of serious injury.
Plain-English summary
CME America, LLC is recalling the CMExpress Microbore Set, REF: A120-160CRV. The recall involves 402,026 units of the product. The affected lots are all within their expiry dates.
The recall is being issued because the infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. The use of the infusion pump system could cause over-infusion or under-infusion of therapy.
The product was distributed in the United States to the following states: CA, IN, LA, MO, FL, IL, ME, MN, CO, VA, OK, NE, GA, AL, KY, IA, MS, ID, TX, SC, OH, SD, NV, MI, WY, NC, PA, TN, KS, NJ, OR, AR, NM, MA, NY, DC, RI, MD, WA, WI, AZ, NH, UT, HI, AK, MT, ND, VT, and CT. The product was also distributed to Canada and the UK. Users should stop using the affected sets and contact the manufacturer for instructions.
The recalled product
- Product
- CMExpress Microbore Set, REF: A120-160CRV
- Manufacturer
- CME America, LLC
- Affected units
- 402,026
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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