Insight Instruments MIS ( Multi-Port Illumination System) Illuminated pilot tubes work like a ceiling light while simult

FDA device recall Z-1281-2013 · posted 2013-05-10 · Terminated

Recall details

Recalling firm

Insight Instruments, Inc.

Reason for recall

Insight Instruments, Inc., Stuart, FL is recalling M.I.S. (Multi-Port Illumination System), Ophthalmic Cannula due to a misclassification of the medical device.

Action taken

Insight Instruments, Inc. sent a recall letter dated March 15, 2013, to all affected customers The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to do the following: 1)Perform a physical count of their inventory immediately for any of the recalled lots and complete and return the Return Response Form. 2) If they have any products listed, contact the firm at (800) 255-8354, to arrange for return and prompt replacement. 3) Discontinue using and dispensing all M.I.S. devices of the recalled lots.

Root cause

Use error

Status

Terminated

Product code

HMX

Quantity affected

776

Distribution

US Distribution IN and IL

Date initiated

2013-03-15

Date posted

2013-05-10

Date terminated

2014-08-21

Location

Stuart, FL