Recall Z-3226-2017 ยท MJC Catheter, Urological (Antimicrobial) And Accessories
C.R. Bard, Inc.
Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheter Female, 14 FR (30/box), Rx Only intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures.
| Date | Jul 28, 2017 |
| Status | Terminated |
| Reason | Specific lots labeled as an Antibacterial Hydrophilic Intermittent Catheter may lack the hydrophilic coating. |
| Root cause | Employee error |
| Action | Customers were notified via letter on 07/28/2017. Instructions included to examine their inventory and identify affected product and notify customers if further distributed. Bard Medical Division asks that customers contact customer service at 1-800-526-4455 if any affected units do not meet their needs. |
| Quantity | 45,270 units |
| Distribution | Distribution to AL, AZ, CA, FL, GA, IL, IN, KS, KY, MA, MO, NC, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033477 | HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT Rochester Medical Corp., Jun 10, 2004 |