Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
BodyGuard Microset with Male Luer Connectors Recalled by CME America, LLC Due to Infusion administration sets may have a delivery inaccuracy...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact CME America, LLC directly.
Affected Products
BodyGuard Microset with Male Luer Connectors, REF: A100-163XEBF
Quantity: 8016
Why Was This Recalled?
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
Where Was This Sold?
This product was distributed to 49 states: AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WI, WY, DC
About CME America, LLC
CME America, LLC has 47 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report