Recall Z-1463-2024 ยท EZN Dilator, Catheter, Ureteral
Coloplast Manufacturing US, LLC
Ureteral dilator, REF RBD014
| Date | Apr 2, 2024 (initiated Mar 11, 2024) |
| Status | Open, Classified |
| Reason | A possible sterility issue (e.g. a breach in sterile packaging) was detected in Coloplast's facility on some ureteral dilator products. This issue on the ureteral dilator packaging has been identified during testing in our facility. |
| Root cause | Under Investigation by firm |
| Action | Coloplast issued an URGENT MEDICAL DEVICE VOLUNTARY RECALL notice to its consignees on 03/11/2024 via USPS first class mail. The notice explained the issue and requested the consignee contact the firm ( Email: urology@coloplast.com, Phone: 800-258-3476) for a refund for returned product. |
| Quantity | 710 units |
| Distribution | US: GA, MS, TN, MN, AZ,N MD, LA, KS, WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170531 | Ureteral Dilators and Percutaneous Nephrostomy Dilators Coloplast Corp., Aug 17, 2017 |