Z-0119-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 26, 2016
- Initiation Date
- August 11, 2016
- Termination Date
- April 27, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 72 units
Product Description
25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 70025E, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
Reason for Recall
Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
Distribution Pattern
Devices were distributed to KY, VA, TN, OH, IN, CA, NJ, NY, TX, SC, AL, MS, MI, and UT. Foreign distribution to the UK, France, Mexico, and India.
Code Information
Lot number M545040 (1 each or box of 6 each), exp 10/2018 Lot number M586070 (1 each or box of 6 each), exp 03/2019