Z-0144-2014 Class II Terminated
FDA device recall Z-0144-2014 was initiated by Insight Instruments, Inc. on June 27, 2013 and is designated Class II. 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. The recall status is terminated (terminated September 27, 2017). Affected quantity: 10212.
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