Class II Recall

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

Summary

The FDA issued a Class II for SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5 by Stryker Corporation. 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 .

Details

Source

Device Recall

External ID

Z-1474-2023

Action Date

2023-05-10

Status

Ongoing

Product 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

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

Quantity Affected: 5,228

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.

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2023-03-02

Company

Stryker Corporation

San Jose, CA

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 168 device recalls issued in the same week, part of 403 device-related FDA actions this month.

Stryker Corporation has 98 FDA actions in our database, including 90 recalls and 8 clearances.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Stryker Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Stryker Corporation have FDA actions?

Stryker Corporation has 98 FDA actions in our database, including 90 recalls and 8 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-1474-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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