Fast-Cath recallZ-0783-2020 · Abbott Medical · initiated Dec 9, 2019
Class II Terminated
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 Abbott Medical 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
Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of the expected 14F devices.
FDA root cause category: Packaging
What the company is doing
Beginning on 12/09/2019, consignees were notified in person by an Abbott field representative. The firm is seeking return of the affected units. For questions about this issue or for replenishment contact your local Abbott Representative or Abbott Support at 1-855-478-5833 (option 1).
Recall details
- Recall number
- Z-0783-2020
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Dec 9, 2019
- Recalling firm
- Abbott Medical
- Quantity
- 814 devices
- Product code
- DYB
- FDA submissions
- K954317
- Distribution
- Worldwide Distributed - US Nationwide in sates of: FL, PA, NY, TX, MI CA, IL, NE, AL, NV, including PR and the countries of: Malaysia, Korea, Paraguay
Product description
Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Code information (models, lots, serial numbers)
UDI: (01)15414734203903(17)220731(10)7133555, Batch: 7133555
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Fast-Cath™ 406303St. Jude Medical, Inc. · INTRODUCER, CATHETER1 recall226 reports
Product lines
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 18, 2026. Text above is shown as published by the FDA.
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