Z-1294-2025Class II

TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP

Name: Z-1294-2025 TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP
Creator: TAS Medical Inc
Published: 2025-01-27
License: https://open.fda.gov/license/

TAS Medical Inc / initiated 2025-01-27 / Open, Classified / root cause: design

FDA source

TAS Medical Inc began a recall of TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP on 2025-01-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1294-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-27
Posted: 2025-03-06
Recalling firm: TAS Medical Inc
Product: TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP
Product code: GAR Suture, Nonabsorbable, Synthetic, Polyamide
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.
Root cause tag: design
FDA root cause: Device Design
Action: On 1/27/2025, correction notices were emailed to customers who were asked to do the following: 1) Firm has developed and validated an interim method for conditioning the product in the surgical suite just prior to implantation to rehydrate the zip-tie straps per these instructions. To reverse the effects of dehydration, when preparing for surgery, submerge the TAS zip-tie straps in 40-degreesC (104-degrees F) sterile saline solution for 60 minutes prior to implantation. The orange leader material is not subject to dehydration and therefore is not required to be soaked. 2) Quarantine affected devices and insert the rehydration procedure into each of the remaining product boxes in your inventory at which point it can be released from quarantine. 3) Firm is is in the process of redesigning its packaging to prevent dehydration of the straps and will let you know when the new packaging is available. We anticipate that it may take up to six months to redesign the packaging, validate it, and release it to the field. Until then, the above rehydration procedure will restore the hydration to the straps in the surgical suite thereby preventing breakage that has been seen in the field. 4) Complete and return the acknowledgement and receipt form via email to [email protected] Questions can be directed to the firm at (716) 997-2896 Monday through Friday between the hours of 8am and 5pm, EST.
Quantity in commerce: 114
Distribution: US Nationwide distribution in the states of LA, OK, TN.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1294-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1294-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-12	2025-03-06

Product code GAR

K220980Class IITissue Approximation System (TAS)Tas Medical, Inc. / cleared 2023-07-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)