25 gauge VersaVit 2.0 Procedure Pack with Mid-Field Illuminator, Product/Part Number 70025S, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
This recall has been terminated (originally issued October 18, 2016).
- Company
- Synergetics Inc
- Recall Initiated
- August 11, 2016
- Posted
- October 18, 2016
- Terminated
- April 27, 2017
- Recall Number
- Z-0120-2017
- Quantity
- 72 units
- Firm Location
- O Fallon, MO
- Official Source
- View on FDA website ↗
Reason for Recall
Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
Distribution
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.
Lot / Code Info
Lot number M548370 (1 each or box of 6 each), exp 11/2018 Lot number M578150 (1 each or box of 6 each), exp 02/2019
Root Cause
Other
Action Taken
A customer notification letter was sent out on 8/11/2016 to the hospital/surgical center level. Customers were asked to fill out and return a recall acknowledgment form and send back any affected devices.
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