Intuitive Surgical, Inc.: 8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400

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: 14,507 Lot/code info: Model Number: 471400 Part Number: 471400-10 UDI-DI code: 00886874121528 Batch Numbers: K10221106 K10221212 K10230129 K10230205 K10230212 K10230219 K10230226 K10230413 K10230504 K10230515 K10230518 K10230525 K10230601 K10230608 K10230615 K10230630 K10230713 K10230720 K10230817 K10230824 K10230831 K10230913 K10230917 K10230928 K10231005 K10231012 K10231019 K10231027 K10231102 K10231130 K10231218 K10240104 K10240116 K10240208 K10240322 K10240327 K10240404 K10240411 K10240516 K10240523 K10240606 K10240613 K10240618 K11221106 K11230129 K11230515 K11230824 K11231012 K11240104 K11240404 K11240702

UPC codes

00886874121528

Source

Official record: FDA (Device enforcement) ↗

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