Recall Z-0844-2025 ยท EZL Catheter, Retention Type, Balloon
Coloplast Manufacturing US, LLC
Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.
| 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 | 226,452 units |
| Distribution | US Nationwide. Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K233411 | Folysil Silicone Catheter Coloplast Corp., Apr 15, 2024 |