Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA612
FDA device recall Z-0844-2025 · posted 2025-01-10 · Open, Classified
Recall details
- Recalling firm
- Coloplast Manufacturing US, LLC
- Reason for recall
- A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
- Action taken
- 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 assistance: Email: IURecalls@coloplast.com Phone: +1 855 745 8549 Expenses will be refunded by Coloplast A/S upon receipt of the completed Certificate of Destruction provided in Appendix 2.
- Root cause
- Packaging
- Status
- Open, Classified
- Product code
- EZL
- Quantity affected
- 226,452 units
- Distribution
- US Nationwide. Canada.
- Date initiated
- 2024-12-02
- Date posted
- 2025-01-10
- Location
- Minneapolis, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Folysil Silicone Catheter (K233411) | Coloplast Corp. | 2024-04-15 |