FEI 3029835193

Tas Medical, Inc.

9100 Conroy Windermere Rd, Windermere, FL, US

MDR events0All time

Recalls1All time

Registered products1

Establishment typeComplaintComplaint File Establishment per 21 CFR 820.198

Registered product codes

1 product codes

Recent MDR events

0 on file

No MDR events on file for this firm name.

Recalls

1 on file

Open, ClassifiedMar 6, 2025
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.
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Compliance history

Matched by FEI 3029835193.

FDA inspections

2 on file

Voluntary Action Indicated (VAI)Aug 15, 2025
Compliance: Devices · Citations posted
No Action Indicated (NAI)Aug 15, 2025
Postmarket Assurance: Devices · Citations posted

Inspection citations

1 on file

Top cited requirements

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21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
1

21 CFR 820.50Aug 15, 2025
Purchasing controls, Lack of or inadequate procedures

Compliance actions

0 on file

No warning letters or injunctions on file for this FEI number.

Import refusals

0 on file

No import refusals on file for this FEI number.