The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2580-2020·Announced 2020-07-22

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 minimum severity score of 4 per the rubric, as Class I recalls involve a reasonable probability of serious adverse health consequences or death.

Plain-English summary

CME America, LLC is recalling 50,122 units of CMExpress Microbore Sets, Reference A120-161C. The recall covers all lots within their expiration dates. These medical devices are used for infusion administration.

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 therapy.

The affected products were 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 products were also distributed to Canada and the United Kingdom. Healthcare facilities and consumers should stop using these sets and contact the manufacturer for instructions on return or replacement.

The recalled product

Product
CMExpress Microbore Sets, REF: A120-161C
Manufacturer
CME America, LLC
Category
Medical Device — Infusion Sets
Hazard
Affected units
50,122

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

Distributed in 49 states:

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 →

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