Z-2539-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 24, 2016
- Initiation Date
- June 29, 2016
- Termination Date
- December 12, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3460 units
Product Description
TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
Reason for Recall
TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.
Distribution Pattern
US Nationwide Distribution
Code Information
model number CMRM3122 lot number 15F30614 15F30614-A 15H10630 15K29659 16B05695 model number CMRM3133 lot number 15F18607 15G14620 15J29647 16C03706