PowerPort ClearVUE recallZ-1964-2020 · Bard Peripheral Vascular Inc · initiated Jan 15, 2020
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 Bard Peripheral Vascular Inc 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
The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock per device labeling.
FDA root cause category: Employee error
What the company is doing
The recalling firm issued letters dated 1/15/2020 via FedEx with proof of delivery notification. The devices were to be returned.
Recall details
- Recall number
- Z-1964-2020
- Status
- Open, Classified
- Initiated by the company
- Jan 15, 2020
- Recalling firm
- Bard Peripheral Vascular Inc
- Quantity
- 200 units
- Product code
- LJT
- FDA submissions
- K122899
- Distribution
- US Nationwide distribution including in the states of AZ, CA, MA, MD, NJ, NY, and TX. There was no foreign/government/military distribution.
Product description
BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Septum and Attachable 6 F Polyurethane Open-Ended Single-Lumen Venous Catheter, Product #5676300 - Product Usage: All materials are biocompatible, can be used with virtually all injectable solutions intended for medicinal use, including the power injection of contrast media.
Code information (models, lots, serial numbers)
Lot #RECX3530, Exp. date 4/30/2020, UDI (01)00801741110771(17)200430(10)RECX3530.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- PowerPort ClearVUE 5676300Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR2 recalls1 death19 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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