25 gauge VersaVit 2.0 Core Essentials Procedure Pack recall
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.
Why was 25 gauge VersaVit 2.0 Core Essentials Procedure Pack recalled?
Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- 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.
- Recalling firm
- Synergetics Inc
- Quantity
- 72 units
- 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.
- Recall date
- October 26, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)