Drug recall
TRYX Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers…
FDA recall event 74672 · Class II · TYRX Inc.
Key facts
| Event ID | 74672 |
|---|---|
| Recall numbers | Z-2539-2016, Z-2540-2016, Z-2541-2016 |
| Recalling firm | TYRX Inc. |
| Product type | Devices |
| Products | TRYX Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD), TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD), TRYX Neuro Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD) |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated. |
| Initiation date | Jun 29, 2016 |
| Report date | Aug 24, 2016 |
| Termination date | Dec 12, 2017 |
| City | Monmouth Junction |
| State | NJ |
| Country | United States |
| FEI number | 3005619263 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: