Device product
TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
Z-2539-2016
Product summary
- Firm
- TYRX Inc.
- Event
- Event 74672
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3460 units
- Official record key
device-enforcement:Z-2539-2016
Official wording
Reason: TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.
Code information: model number CMRM3122 lot number 15F30614 15F30614-A 15H10630 15K29659 16B05695 model number CMRM3133 lot number 15F18607 15G14620 15J29647 16C03706
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.