Intuitive Surgical, Inc.: 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000¿ REF 470296

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: 784 Lot/code info: Model Number: 470296 Part Number: 470296-05 UDI-DI code: 00886874112410 Batch Numbers: K10230217 Model Number: 470296 Part Number: 470296-08 UDI-DI code: 00886874112410 Batch Numbers: K10230302 K10230413 K10230420 K10230427 K10230824 K10231123 K10240229 K10240425 K10240627 K10240718 K16240613

UPC codes

00886874112410

Source

Official record: FDA (Device enforcement) ↗

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