Recall Z-0356-2023 ยท FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Cardinal Health
Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter Product Code: 2480 Intended for urinary drainage from the bladder of a patient
| Date | Dec 2, 2022 (initiated Nov 1, 2022) |
| Status | Open, Classified |
| Reason | Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention |
| Root cause | Equipment maintenance |
| Action | Cardinal Health issued Urgent Medical Device Recall Letter (Event-2022-04944) and Acknowledgement Form on November 1, 2022 to the direct consignees. Letter states reason for recall, health risk and action to take: Actions Required: 1. REVIEW your inventory for the affected product codes and lots. Location of product codes and lots are shown in Attachment 1. 2. SEGREGATE and quarantine all affected product upon review of your inventory. 3. NOTIFY any customers to whom you may have distributed/forwarded affected product to or will send the product on to about this product recall notice and sha |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K903340 | STERILE URETHRAL CATHETER PROCEDURE KITS Superior Healthcare Group, Inc., Oct 4, 1990 |