Summary
The FDA issued a Class II for TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP by TAS Medical Inc. Reason: Tissue approximation straps (zip-ties) have broken before or during implantation so firm developed an interim zip-tie conditioning method submerging z.
Details
Source
Device Recall
External ID
Z-1294-2025
Action Date
2025-03-12
Status
Ongoing
Category
device
Product Description
TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP
Lot/Code Info: 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)
Quantity Affected: 114
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 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.
Distribution
US Nationwide distribution in the states of LA, OK, TN.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-01-27
Company
Windermere, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 132 device recalls issued in the same week, part of 403 device-related FDA actions this month.
TAS Medical Inc has 3 FDA actions in our database, including 1 recall and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (TAS Medical Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does TAS Medical Inc have FDA actions?
TAS Medical Inc has 3 FDA actions in our database, including 1 recall and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1294-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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