SureStep Intermittent Catheter Tray recallZ-0666-2022 · C.R. Bard Inc · initiated Jan 27, 2022
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
There is a potential to leak from the catheter where it connects to the drain bag
FDA root cause category: Under Investigation by firm
What the company is doing
The firm initiated the recall on 01/27/2022 by letter. The letter explained the issue and the hazard and requested consignee destroy any product on hand. Distributors were directed to destroy all product on hand and to notify their customers of the recall.
Recall details
- Recall number
- Z-0666-2022
- Status
- Terminated
- Initiated by the company
- Jan 27, 2022
- Recalling firm
- C.R. Bard Inc
- Quantity
- 2120 units
- Product code
- KOD
- FDA submissions
- K000723
- Distribution
- US Nationwide distribution in the states of GA, ME, NJ, WI, MN, SD, CO, ND, ID, IL, FL, LA, MD, PA, OH, NE.
Product description
BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C
Code information (models, lots, serial numbers)
Serial Number/UDI NGEWX106/(01)00801741183232(17) NGEWX143/(01)00801741183232(17) NGFQ0368/(01)00801741183232(17) NGEW9106/(01)00801741183232(17)
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- SureStep Intermittent Catheter Tray INTS14CC. R. Bard, Inc. · CATHETER, UROLOGICAL2 recalls4 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 89288).
- Z-0667-2022 · TerminatedBARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C
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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