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 device recall Z-1474-2023 · posted 2023-04-28 · Open, Classified
Recall details
- Recalling firm
- Stryker Corporation
- 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.
- Action taken
- 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
- Root cause
- Employee error
- Status
- Open, Classified
- Product code
- FCW
- Quantity affected
- 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,
- Date initiated
- 2023-03-02
- Date posted
- 2023-04-28
- Location
- San Jose, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STRYKER LED LIGHTSOURCE (K082813) | Stryker Corp. | 2008-12-19 |