Recall Z-2075-2025 ยท KOD Catheter, Urological
C.R. Bard Inc
BD Heyman Follower Coude Tip for following sizes: 12Fr - REF:021312 14Fr - REF:021314, 16Fr - REF: 021316
| Date | Jul 3, 2025 (initiated Jun 3, 2025) |
| Status | Open, Classified |
| Reason | Cather packaging may contain the incorrect French size. |
| Root cause | Under Investigation by firm |
| Action | On June 3, 2025, BD (C.R. Bard) Urology and Critical Care issued a "Urgent Medical Device Recall Notification to affected consignees via. Fed Ex and E-mail. On June 18, 2025, BD issued a updated recall notification to update incorrect lot numbers. BD asked consignees to take the following actions: 1. Immediately Discontinue Use 2. Please check all inventory locations within your institution for impacted lots of BD C.R. Bard Heyman" Follower Straight Tip Fr Sizes 10, 12, 14, 20; Heyman Follower Coude Tip Fr Sizes 12, 14, 16; BARD Urologist s Trays listed on Attachment 2. 3. Immediately qua |
| Distribution | Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WI, WV and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.