Recall Z-1970-2020 ยท MJC Catheter, Urological (Antimicrobial) And Accessories
C.R. Bard Inc
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.
| Date | Apr 15, 2020 |
| Status | Terminated |
| Reason | There is potential for a white paper-type residue attached to the catheter. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 8392 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040658 | BARDEX I.C. LATEX FOLEY CATHETER C.R. Bard, Inc., Sep 29, 2004 |