SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT 3.05M, REF: 0233-050-200
FDA Recall Z-1474-2023 · Posted 2023-04-28
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Recalling FirmStryker Corporation
Recall StatusOpen, Classified
Product CodeFCW
Date Initiated2023-03-02
Product Quantity5,228
Reason for Recall
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.
Firm 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]
Root Cause
Employee error
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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