FDA Medical devices recall ·
TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP recall
- Recall number
- Z-1294-2025
- Date
- (initiated January 27, 2025)
- Company / brand
- TAS Medical Inc
9100 Conroy Windermere Rd Ste 200, Windermere, FL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 114
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model/UDI-DI/Lot(Expiration): T-4000/00197644217267/230403(2024/04/20); T-5000/00860011435921/240801(2025/08/28), 240901(2025/09/25); T-LAP/00860011435914, 00197644927241/240702(2025/07/08), 230906(2024/11/29), 230905(2024/11/29)
Distribution
US Nationwide distribution in the states of LA, OK, TN.
States: Louisiana Oklahoma Tennessee
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1294-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.