—#181279

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.

FDA product code: MJC — Catheter, Urological (Antimicrobial) And Accessories
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K040658
Affected lot / code info: 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)

Why it was recalled

There is potential for a white paper-type residue attached to the catheter.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: C.R. Bard Inc
Address: 8195 Industrial Blvd NE, Covington, Georgia 30014-1497

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2020-04-15
Terminated: 2021-05-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181279. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.