FDA (Devices) recall action 78951
The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.
Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the Tyvek may not be coated completely causing gaps in the adhesive used to seal the product packaging. This potential lack of adhesive may affect the sterility of the product.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Vygon is voluntarily recalling 300 units of CVC Tray Pediatrics because packaging adhesive gaps may compromise sterility.
Vygon is voluntarily recalling 156 units of 19Ga x 1 Huber Needle Sets because packaging adhesive issues may compromise product sterility.
Vygon is voluntarily recalling specific lots of Nutrisafe 2 syringes because packaging adhesive gaps may compromise sterility.
Vygon is voluntarily recalling 200 units of 3-Way Standardbore Stopcocks because packaging adhesive issues may compromise product sterility.
Vygon is voluntarily recalling 396 units of LifeGuard Huber Needles because packaging adhesive gaps may compromise sterility.