Reported Oct 26, 2016 · Terminated
25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator, Product/Part Number 70025SP, packaged in HIPS…
Synergetics Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Synergetics Inc · 3845 Corporate Centre Dr · O Fallon, MO · 63368-8678
Is this the product you have?
- 25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator, Product/Part Number 70025SP, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
- Lot codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 Lot number M543990 (1 each or box of 6 each), exp 10/2018 2 Lot number M545780 (1 each or box of 6 each), exp 10/2018 3 Lot number M569020 (1 each or box of 6 each), exp 01/2019 4 Lot number M578140 (1 each or box of 6 each), exp 02/2019 - Amount recalled
- 255 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
This product could cause temporary or reversible health problems — stop using it.
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