FDA-Device2016-08-24Class II
TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
TYRX Inc.
Hazard
TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.
Sold states
US Nationwide Distribution
Affected count
3460 units
Manufactured in
1 Deerpark Dr Ste G, N/A, Monmouth Junction, NJ, United States
Products
TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2539-2016Don't want to check this manually?
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