Fast-Cath recallZ-0789-2020 · Abbott Medical · initiated Dec 9, 2019
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
Three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths instead of the expected 8.5F devices.
FDA root cause category: Packaging
What the company is doing
Beginning on December 9, 2019, US consignees will be notified in person by an Abbott field representative. OUS consignees will be notified by mail. The firm is seeking return of the devices.
Recall details
- Recall number
- Z-0789-2020
- Status
- Terminated
- Initiated by the company
- Dec 9, 2019
- Recalling firm
- Abbott Medical
- Quantity
- 380 devices
- Product code
- DYB
- FDA submissions
- K914090
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of MA, VA, NH, FL, CT, UT, OH, WI, NY, IA, MI, MS, PA, and countries of Canada, Czech Republic
Product description
Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
Code information (models, lots, serial numbers)
Batch 6917183; UDI (01)15414734014219(17)220228(10)6917183 Batch 6950628; UDI (01)15414734014219(17)220331(10)6950628 Batch 7099144; UDI (01)15414734014219(17)220630(10)7099144
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Fast-Cath™ 406143St. Jude Medical, Inc. · INTRODUCER, CATHETER1 recall69 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 16, 2026. Text above is shown as published by the FDA.
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