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FDA (Device enforcement)Recalled 2024-12-19class ii

Intuitive Surgical, Inc.: 8MM,DUAL BLADE RETRACTOR,IS4000¿ REF 470249

Hazard

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Details from the source

Reason for recall: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. Distribution: U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Ok Quantity: 783 Lot/code info: Model Number: 470249 Part Number: 470249-09 UDI-DI code: 00886874112403 Batch Numbers: K10230226 K10230316 K10230323 K10230331 K10230518 K10230824 K10230831 K10231130 K10231214 K10240118 K10240208 K10240222 K10240327 K10240509 K10240711 K10240725 K10240801 K11231116

UPC codes

00886874112403

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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