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TYRX Inc. recalls TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or
Recalled August 24, 2016 · FDA recall Z-2539-2016 · TYRX
Hazard
TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated. · FDA Class II
Units
3460 units
Sold at
US Nationwide Distribution
Description
TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.
Product
TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
Manufacturer(s)
TYRX Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →