BEUDAMED
    FDA Recall Open, Classified

    SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT 3.05M, REF: 0233-050-200

    Recall: Z-1474-2023 · Initiated March 2, 2023

    Recall

    Recall Number
    Z-1474-2023
    Event Number
    91891
    Firm
    Stryker Corporation
    FEI Number
    2936485
    Product Code
    FCW
    Status
    Open, Classified
    Root Cause
    Employee error
    Initiated
    March 2, 2023
    Posted
    April 28, 2023
    Address
    5900 Optical Ct, San Jose, CA, 95138-1400

    Description

    SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT 3.05M, REF: 0233-050-200

    Reason

    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.

    Action

    On 3/2/23 recall notices were mailed to customers who were asked to do the following: 1. Inform individuals within your organization who need to be aware of this action. 2. Identify, remove, and quarantine affected devices. 3. If affected product is found, call customer service at 1-800-624-4422 (Option 3) or email [email protected] to arrange for product return. 4. Complete and return the Business Reply Form Customers with questions can contact [email protected]

    Distribution

    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.

    Quantity

    5,228