Bard Clean-Cath Intermittent Catheter recallZ-1431-2021 · C.R. Bard, Inc. · initiated Jan 11, 2021
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 C.R. Bard, 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 device catheter tip was cut off (no tip) and the product packaging was not fully sealed.
FDA root cause category: Packaging process control
What the company is doing
All customers will be contacted via letters sent via Fed Ex. The acknowledgement form included with the letter that is mailed or faxed back to BD will be reconciled with the customer list. BD will contact 100% of our customers that have not responded to the communication to verify acknowledgement. BD is requesting that customers discard affected components.
Recall details
- Recall number
- Z-1431-2021
- Status
- Terminated
- Initiated by the company
- Jan 11, 2021
- Recalling firm
- C.R. Bard, Inc.
- Quantity
- 9,800 Units
- Product code
- KOD
- FDA submissions
- K802665
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Australia, Canada.
Product description
Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for urological use only.
Code information (models, lots, serial numbers)
Cat. No. 420712/Lot No. NGDY1813/ UDI (GTIN) (01)00801741038730(17)241130(10), Exp. Date 11/30/2024
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Bard® Clean-Cath® Intermittent Catheter 420712C. R. Bard, Inc. · CATHETER, UROLOGICAL1 recall4 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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