Gore Tips Set Device, Catalog Number TSET1016, percutaneous… recallZ-2249-2023 · Creganna Medical Devices · initiated Jun 22, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Creganna Medical Devices or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Three lots of product may be labeled with an incorrect expiration day
FDA root cause category: Process control
What the company is doing
Creganna Medical notified its sole consignee on 06/22/2023 via email. The notice explained the problem with the product and informed the consignee of their intention to collaboratively conduct a recall. The sole consignee is notifying their customers by letter delivered by FedEX on 06/28/2023. The product is to be returned to the consignee.
Recall details
- Recall number
- Z-2249-2023
- Status
- Open, Classified
- Initiated by the company
- Jun 22, 2023
- Posted by the FDA
- Jul 28, 2023
- Recalling firm
- Creganna Medical Devices
- Quantity
- 194 units
- Product code
- DYB
- FDA submissions
- K152913
- Distribution
- US Nationwide distribution in the state of AZ.
Product description
Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access
Code information (models, lots, serial numbers)
UDI/DI 05391526210000, Lot Numbers: 1V00099635, 1V00166928, 1V00199622
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Gore TIPS Needle TNDL1656Creganna Unlimited Company · Introducer, Catheter1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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