Home / Recalls / Insight Instruments, Inc. / Z-0144-2014

Z-0144-2014 Class II Terminated

Recalled by Insight Instruments, Inc. — Stuart, FL

Recall Details

Product Type: Devices
Report Date: November 13, 2013
Initiation Date: June 27, 2013
Termination Date: September 27, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 10212

Product Description

MLS Torpedo Mini-Light Ophthalmic single-port illumination. Sutureless 25- gauge illuminator for vitreo-retinal surgery when full field illumination of bimanual surgery if desired.

Reason for Recall

The product was registered and distributed as a Class I medical device and was subsequently determined to be a Class II medical device which requires FDA market clearance.

Distribution Pattern

Worldwide Distribution - USA (nationwide) including AZ, CA, FL, IN, MA, MD, TX, and WA and Internationally to Czech Republic, Germany, Netherlands, Spain, Switzerland, and Turkey.

Code Information

Part Number Lot Number Expiration 11007 M52934 04/2013 11017 M53017 04/2013 11007 M55285 07/2013 11007 M55869 08/2013 11007 M58610 12/2013 11007 M59575 02/2014 11007 M61781 05/2014