Intuitive Surgical, Inc.: 8MM,TIP-UP FENESTRATED GRASPER,IS4000¿ REF 470347

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: 72,646 Lot/code info: Model Number: 470347 Part Number: 470347-11 UDI-DI code: 00886874112496 Batch Numbers: K10230122 K10230129 K10230227 K10230302 K10230313 K10230316 K10230323 K10230330 K10230405 K10230413 K10230420 K10230427 K10230428 K10230504 K10230511 K10230516 K10230518 K10230525 K10230601 K10230602 K10230608 K10230615 K10230622 K10230629 K10230706 K10230710 K10230713 K10230719 K10230720 K10230727 K10230801 K10230803 K10230810 K10230817 K10230824 K10230831 K10230907 K10230913 K10230914 K10230921 K10230928 K10231005 K10231019 K10231027 K10231102 K10231123 K10231130 K10231218 K10240104 K10240111 K10240116 K10240118 K10240124 K10240125 K10240208 K10240215 K10240218 K10240222 K10240229 K10240303 K10240307 K10240315 K10240322 K10240326 K10240418 K10240425 K10240502 K10240515 K10240516 K10240523 K10240530 K10240606 K10240618 K10240718 K10240725 K10240801 K10240805 K10240808 K10240815 K11230122 K11230313 K11230316 K11230323 K11230330 K11230405 K11230413 K11230420 K11230427 K11230504 K11230511 K11230518 K11230525 K11230601 K11230602 K11230608 K11230615 K11230622 K11230629 K11230706 K11230710 K11230713 K11230719 K11230720 K11230727 K11230803 K11230810 K11230817 K11230824 K11230831 K11230907 K11230914 K11230921 K11230928 K11231005 K11231102 K11231130 K11231218 K11240104 K11240111 K11240118 K11240125 K11240229 K11240307 K11240315 K11240326 K11240418 K11240425 K11240516 K11240523 K11240530 K11240606 K11240725 K11240801 K12230122 K12230313 K12230323 K12230330 K12230405 K12230413 K12230420 K12230427 K12

UPC codes

00886874112496

Source

Official record: FDA (Device enforcement) ↗

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