FDA-Device2023-05-10Class II
SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT 3.05M, REF: 0233-050-200
Stryker Corporation
Hazard
Fiber optic cables assembled with not enough epoxy on the proximal end, creating light output issues, which could cause a clinical delay or procedure being converted to open.
Sold states
Worldwide - US Nationwide distribution including in the states of PA, MS, IL, OH, CA, TX, MO, IN, KS, OK, MT, MA, NE, AZ, NV, NJ, IA, WV, MD, KY, FL, NM, NY, CO, WA, NC, VA, LA, ND, WY, HI SC, UT, OR, SD, AR, TN, AK, CT, GA, ID, VT, NH, MN, WI, DE, RI, AL, MI and the countries of NL, PE, AT, CA, TW, PH, SG, KR, CN.
Affected count
5,228
Manufactured in
5900 Optical Ct, San Jose, CA, United States
Products
SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT 3.05M, REF: 0233-050-200
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1474-2023Don't want to check this manually?
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