SureStep Foley Tray System Bardex IC Complete Care recallZ-1970-2020 · C.R. Bard Inc · initiated Apr 15, 2020
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 potential for a white paper-type residue attached to the catheter.
FDA root cause category: Under Investigation by firm
What the company is doing
Customer/Distributer letters were mailed on April 27, 2020 via FedEx and email. BD will request distributors to conduct a sub-recall on BDs behalf. 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 and distributors discard affected unit(s). Any unit(s) that are returned to BD will be quarantined upon arrival and discarded per procedure.
Recall details
- Recall number
- Z-1970-2020
- Status
- Terminated
- Initiated by the company
- Apr 15, 2020
- Recalling firm
- C.R. Bard Inc
- Quantity
- 8392 units
- Product code
- MJC
- FDA submissions
- K040658
- Distribution
- US Nationwide distribution including in the states of AZ, CA, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MO, NC, NE, NJ, NY, RI, SD, TN, TX, UT, VA, WV.
Product description
SureStep Foley Tray System - Product Usage: Intended for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.
Code information (models, lots, serial numbers)
Catalog Number: A304716A UDI: 00801741104299 Lot Numbers: NGDX4745 (Exp. 03/20/2021); NGDY0567 (Exp. 03/20/2021); NGDW1548 (Exp. 11/30/2021); NGDW0234 (Exp. 11/30/2021); NGDX4088 (Exp. 11/30/2021); NGDX4704 (Exp. 11/30/2021); NGDY0568 (Exp. 11/30/2021)
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- SureStep™ Foley Tray System Bardex® IC Complete Care® A304716AC. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES2 recalls9 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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