Coloplast Manufacturing US, LLC: Device Recall
Recall #Z-0844-2025 · 12/02/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0844-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Coloplast Manufacturing US, LLC
- Status
- Ongoing
- Date Initiated
- 12/02/2024
- Location
- Minneapolis, MN, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 226,452 units
Reason for Recall
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
Product 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.
Distribution Pattern
US Nationwide. Canada.
Other Recalls by Coloplast Manufacturing US, LLC
- Class II: Risk 12/02/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.