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.
Recall
- Recall Number
- Z-0844-2025
- Event Number
- 95895
- Firm
- Coloplast Manufacturing US, LLC
- FEI Number
- 2125050
- Product Code
- EZL
- Status
- Open, Classified
- Root Cause
- Packaging
- Initiated
- December 2, 2024
- Posted
- January 10, 2025
- Address
- 1601 W River Rd, Minneapolis, MN, 55411-3431
Description
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.
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
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: [email protected] 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.
US Nationwide. Canada.
226,452 units