Recall Z-0845-2025 ยท EZL Catheter, Retention Type, Balloon
Coloplast Manufacturing US, LLC
X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB6322, AB6324, AB6418, AB6420, AB6422, AB6424, AB6522, AB6524, AB6A18, AB6A20, AB6A22, AB6A24, AB6C18, AB6C20, AB6C22, and AB6C24.
| Date | Jan 10, 2025 (initiated Dec 2, 2024) |
| Status | Open, Classified |
| Reason | A possible sterility issue was detected in Coloplast's facility on some Coloplast products. |
| Root cause | Packaging |
| Action | An URGENT MEDICAL DEVICE VOLUNTARY RECALL notification letter dated 12/2/24 was sent to customers. Distributors, it is imperative that you take immediate action to cascade this recall notice to all relevant subsidiaries and customers who may have received the affected product within your distribution network. Customers affected by this recall are kindly advised to immediately inspect their internal inventory and quarantine all products and samples of the items with the lot numbers mentioned in Appendix 1 and then proceed to safe destruction. Please contact Customer Service for any assista |
| Quantity | 36,369 units |
| Distribution | US Nationwide. Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013172 | PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL Porges S.A., Dec 20, 2001 |