FDA-Device2023-01-18Class II
RadiaLux Lighted Retractor (Pink), REF: 50-101-1
Medtronic Navigation, Inc.
Hazard
Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection.
Sold states
US Nationwide distribution including in the states of OH, CA, FL, NJ, NY, MN, IN, VA, WA, MS, SC, MO, GA, PA, KS, TN, LA, TX, ME, MA, AL, NC, MD, NH, IL, AZ, MI, NV, MT, OK, SD, RI, CO, CT, NM, NE, DE, WI.
Affected count
2317
Manufactured in
826 Coal Creek Cir, Louisville, CO, United States
Products
RadiaLux Lighted Retractor (Pink), REF: 50-101-1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0953-2023Don't want to check this manually?
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