TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 9311.25K02, 9311.25K03, 9625.G0201;
D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
The hazard
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 9311.25K02, 9311.25K03, 9625.G0201;
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model 1. Article Number: 9268.VIT25Model UDI-DI: 08717872031873Model 2. Article Number: 9311.25G01Model UDI-DI: 08717872035116Model 3. Article Number: 9311.25G02Model UDI-DI: 08717872035345Model 4. Article Number: 9311.25K01Model UDI-DI: N/AModel 5. Article Number: 9311.25K02Model 6. Article Number: 9311.25K03Model 7. Article Number: 9625.G0201Model Lot Numbers: 101118001Model 101799001Model 101800001Model 102675001Model 102676001Model 103507001Model 103508001Model 103509001Model 104360001Model 50489-*-*-1Model 54992-*-*-1UPC 08717872031873UPC 08717872035116UPC 08717872035345Would you have heard about this one?
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