Recall Z-2064-2018 ยท EZC Catheter, Coude
C.R. Bard, Inc.
Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22Fr. Rx (01267522)
| Date | Dec 13, 2017 |
| Status | Terminated |
| Reason | Foley Catheter with Incorrect Retainer Cap Print |
| Root cause | Process control |
| Action | On December 13, 2017 a letter was sent to all their customers informing them of the following: Bard Medical Division (BMD), C.R Bard, Inc., would like to inform you of a potential labeling issue involving the BARD product code and lot numbers listed below. Manufacturing of these affected products began May 2017.Due to a manufacturing issue, there is a potential for catheters with the two lot numbers listed above to have the incorrect information printed on the purple retainer cap. The incorrect print specifies that the balloon should be inflated with 10mL of water. However, the correct vol |
| Distribution | FL, NY, MN and TX Canada, Japan and Taiwan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K910195 | BARD HYDROGEL-COATED FOLEY CATHETERS C.R. Bard, Inc., Aug 9, 1991 |