Recall Z-1474-2023 ยท FCW Light Source, Fiberoptic, Routine
Stryker Corporation
SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT 3.05M, REF: 0233-050-200
| Date | Apr 28, 2023 (initiated Mar 2, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Employee error |
| 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 endocustomersupport@stryker.com to arrange for product return. 4. Complete and return the Business Reply Form Customers with questions can contact EndoRecall@stryker.com |
| Quantity | 5,228 |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082813 | STRYKER LED LIGHTSOURCE Stryker Corp., Dec 19, 2008 |