CME America Recalls CMExpress Microbore Sets Due to Delivery Inaccuracy
CME America is recalling 4,234 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, which are considered serious hazards.
Plain-English summary
CME America, LLC is recalling 4,234 units of CMExpress Microbore Sets, reference number A120-160C2YRV. The recall covers all lots within their expiration dates.
The recall was initiated because the infusion administration sets may have a delivery inaccuracy ranging from minus 42.8% to plus 17.5%, which exceeds the acceptable limit of plus or minus 13%. The use of these sets with an infusion pump system could result in the over-infusion or under-infusion of medical therapy.
The affected products were distributed in the United States to the following states and districts: 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 products were also distributed to Canada and the United Kingdom. Healthcare facilities and consumers should stop using these sets and contact the manufacturer for further instructions.
The recalled product
- Product
- CMExpress Microbore Sets, REF: A120-160C2YRV
- Manufacturer
- CME America, LLC
- Category
- Medical Device — Infusion Sets
- Affected units
- 4,234
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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