Intuitive Surgical, Inc.: 8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006

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: 10,603 Lot/code info: Model Number: 470006 Part Number: 470006-12 UDI-DI code: 00886874112151 Batch Numbers: K10230120 K10230118 K12230119 K11230118 K10230217 Part Number: 470006-13 UDI-DI code: 00886874112151 Batch Numbers: K10230623 K10240506 K10240815

UPC codes

00886874112151

Source

Official record: FDA (Device enforcement) ↗

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