—#199110

Product

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 product code: FCW — Light Source, Fiberoptic, Routine
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K082813
Affected lot / code info: Ref/UDI-DI/Lot: 0233-050-100/07613327051650/159190, 159191, 159192, 159194, 159195, 159196, 159197, 159198, 159199, 159200, 159201, 159202, 159203, 159204, 159205, 159206, 159207, 159208, 159209, 159210, 159211, 159212, 159213, 159214, 159215, 159216, 159217, 159218, 164764, 164765, 164766, 164767, 164768, 164769, 164770, 164771, 164772, 164773, 164774, 164775, 164776, 164777, 164778, 164779, 164780, 164781, 164782, 164783, 164784, 164785, 164786, 164787, 164788, 164789, 164790, 164791, 164792, 164793, 164794, 164795, 164796, 164797, 164798, 164799, 164800, 164801, 164802, 164803, 164804, 164805, 164806, 164807, 164808, 164809, 164810, 164811, 164812, 164813, 164814, 164815, 164816, 164817, 164818, 164819, 164820, 164821, 164822, 168940, 168941, 168942, 168943, 168944, 168945, 168946, 168947, 168948, 168949, 168950, 168951, 168952, 168953, 168954, 168955, 168956, 168957, 168958, 168959, 168960, 168961, 168962, 168963, 168964, 168965, 168966, 168967, 168968, 168969, 168970, 168971, 168972, 168973, 168974, 168975, 168976, 168977, 168978, 168979, 168980, 168981, 168987; 0233-050-200/07613327051643/158865, 158868, 158869, 158872, 158874, 158875, 158878, 158884, 165446, 165448, 165451, 165457, 165458, 165459, 165461, 165462, 165464, 168909, 168910, 168911, 168912, 168913, 168914, 168915, 168916, 168917, 168918, 168919, 168920, 168921, 168923, 168924, 168925, 168926, 168927, 168928

Why it was recalled

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 (FDA determination)

Employee error

Action the firm took

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

Recalling firm

Firm: Stryker Corporation
Address: 5900 Optical Ct, San Jose, California 95138-1400

Distribution

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.

Timeline

Recall initiated: 2023-03-02
Posted by FDA: 2023-04-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #199110. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.