FDA Device recall Z-2539-2016
TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverte…
- FDA Device
- Class II
- terminated
- Published 2016-08-24
On 2016-08-24 the FDA classified a Class II recall of TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverte… by Tyrx, citing TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2539-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-06-29 |
| Published | 2016-08-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Tyrx |
| Distribution | US |
Product
TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
Reason
TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.
Identifiers
| code_info | model number CMRM3122 lot number 15F30614 15F30614-A 15H10630 15K29659 16B05695 model number CMRM3133…model number CMRM3122 lot number 15F30614 15F30614-A 15H10630 15K29659 16B05695 model number CMRM3133 lot number 15F18607 15G14620 15J29647 16C03706 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2539-2016%22
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