Drug recall
TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP
FDA recall event 96274 · Class II · TAS Medical Inc
Key facts
| Event ID | 96274 |
|---|---|
| Recall numbers | Z-1294-2025 |
| Recalling firm | TAS Medical Inc |
| Product type | Devices |
| Products | TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Tissue approximation straps (zip-ties) have broken before or during implantation so firm developed an interim zip-tie conditioning method submerging zip-ties in 104-degrees F sterile saline solution… |
| Initiation date | Jan 27, 2025 |
| Report date | Mar 12, 2025 |
| City | Windermere |
| State | FL |
| Country | United States |
| FEI number | 3029835193 |
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: