SureStep Foley Tray (C.R. Bard) – Residue Issue (2020)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
C.R. Bard Inc
Lot Codes / Batch 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)
Products Sold
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)
C.R. Bard Inc is recalling SureStep Foley Tray System - Product Usage: Intended for use in the drainage and/or collection and/o due to There is potential for a white paper-type residue attached to the catheter.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is potential for a white paper-type residue attached to the catheter.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026