FDA Medical devices recall ·
X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024… recall
- Recall number
- Z-0845-2025
- Date
- (initiated December 2, 2024)
- Company / brand
- Coloplast Manufacturing US, LLC
1601 W River Rd, Minneapolis, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 36,369 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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, 9090787, 9112219, 9122900, 9304719, 9341183, 9341188, 9362273, 9374219, 9374226, 9396727, 9396729, 9396730, 9420755, 9420756, 9429254, 9445832, 9445833, 9453638, 9472408, 9498273, 9530041, 9553590, 9792275; Device Reference Number AB6322, GTIN 3600040144459, Lot Numbers: 7338758, 7350593, 7713988, 772
Distribution
US Nationwide. Canada.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0845-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.