TYRX Inc. recalls TRYX Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or…

Recall date

June 29, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2540-2016

FDA classification

Class II

Brand / firm

TYRX Inc.

Sold / distributed

US Nationwide Distribution

Why it was recalled

TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

TRYX Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)