Recall Z-0844-2025— Coloplast Manufacturing US, LLC
Class II · Ongoing
Class II FDA medical device recall by Coloplast Manufacturing US, LLC, initiated 2024-12-02. It names one FDA 510(k) clearance: K233411. Product: 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.. Reason: A possible sterility issue was detected in Coloplast's facility on some Coloplast products..
- Recalling firm
- Coloplast Manufacturing US, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-12-02
- Firm location
- Minneapolis, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Reason for recall
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
Data sourced from openFDA. This site is unofficial and independent of the FDA.