FDA recall Z-0845-2025

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.

Reason for recall

A possible sterility issue was detected in Coloplast's facility on some Coloplast products.

Distribution

US Nationwide. Canada.

Key facts

Status

Ongoing

Initiation date

2024-12-02

Report date

2025-01-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0845-2025