FDA (Devices) recall action 74672
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.
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.
TYRX Inc. is recalling 2,993 units of the TRYX Absorbable Antibacterial Envelope because key manufacturing processes were not adequately validated.
TYRX Inc. is recalling 3,460 units of TRYX Antibacterial Envelopes because manufacturing processes were not adequately validated.
TYRX Inc. is recalling 194 units of the TRYX Neuro Absorbable Antibacterial Envelope because manufacturing processes were not adequately validated.