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U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

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Product Detail

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.
Recall Number Z-0144-2014
Classification Class II
Code Info 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
Product Distributed Qty 10212
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.

Event Detail

Event Id 66040
Product Type Devices
Status Ongoing
Recalling Firm Insight Instruments, Inc.
City Stuart
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-27
Initial Firm Notification of Consignee or Public Letter
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.