Coloplast Manufacturing US, LLC: Device Recall
Recall #Z-0845-2025 · 12/02/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0845-2025
- 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
- 36,369 units
Reason for Recall
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
Product Description
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.
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.