Recall Z-0845-2025
Coloplast Manufacturing US, LLC · initiated December 2, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Device Reference Number AB6022, GTIN 3600040143377, Lot Numbers: 8884608, 9132241, 9213522, 9396680, 9404775, 9495823, 9495824 ; Device Reference Number AB6024, GTIN 3600040143506, Lot Numbers: 8156931, 8865281, 9102857, 9453594 ; Device Reference Number AB6118, GTIN 3600040143636, Lot Numbers: 8691180; Device Reference Number AB6120, GTIN 3600040143728, Lot Numbers: 8839916, 9090719, 9112199, 9177734, 9622870, 9690290 ; Device Reference Number AB6122, GTIN 3600040143810, Lot Numbers: 7562886, 7562887; Device Reference Number AB6124, GTIN 3600040143902, Lot Numbers: 7396107, 9102869, 9429206 ; Device Reference Number AB6220, GTIN 3600040144046, Lot Numbers: 8460192, 8529285; Device Reference Number AB6222, GTIN 3600040144091, Lot Numbers: 8442243, 8459924, 8529346, 8592925, 8806400; Device Reference Number AB6224, GTIN 3600040144145, Lot Numbers: 8442214, 8559578, 9112300 ; Device Reference Number AB6318, GTIN 3600040144190, Lot Numbers: 7637490, 7670546, 8484834, 8498250, 8529294, 8529295 ; Device Reference Number AB6320, GTIN 3600040144329, Lot Numbers: 7416561, 8030228, 8268284, 8296927, 8296928, 8296931, 8296942, 8296955, 8484916, 8691201, 8749915, 9008517, 9008535, 9067831…
Reason for recall
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
FDA-determined cause: Packaging
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.
Details
- Recall number
- Z-0845-2025
- Initiated
- December 2, 2024
- Posted by FDA
- January 10, 2025
- Product code
- EZL – Catheter, Retention Type, Balloon
- Quantity
- 36,369 units
- Distribution
- US Nationwide. Canada.
- Recalling firm
- Coloplast Manufacturing US, LLC, Minneapolis, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0844-2025 Class II | Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110…A possible sterility issue was detected in Coloplast's facility on some Coloplast products. | 12/02/2024Open, Classified |