Reported Mar 12, 2025 · Ongoing
TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP
TAS Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: TAS Medical Inc · 9100 Conroy Windermere Rd Ste 200 · Windermere, FL · 34786-8431
Is this the product you have?
- TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP
- Lot codes and dates
3 of 3 products
Products covered by this recall # Barcodes Product as published 1 00197644217267T-4000/00197644217267/230403(2024/04/20) 2 00860011435921T-5000/00860011435921/240801(2025/08/28), 240901(2025/09/25) 3 0086001143591400197644927241T-LAP/00860011435914, 00197644927241/240702(2025/07/08), 230906(2024/11/29), 230905(2024/11/29) - Amount recalled
- 114
Where it was sold
Why it was recalled
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 for 60 min prior to implantation to rehydrate the zip-tie straps. Broken zip-ties not observed during procedure could lead to future hernia recurrence, recurrent surgery to correct a large herniation.
This product could cause temporary or reversible health problems — stop using it.
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