Reported Jan 22, 2025 · Ongoing
X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222,…
Coloplast Manufacturing US, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Coloplast Manufacturing US, LLC · 1601 W River Rd · Minneapolis, MN · 55411-3431
Is this the product you have?
X-Flow prostatectomy catheterDevice Reference Numbers AB6022AB6024AB6118AB6120AB6122AB6124AB6220AB6222AB6224AB6318AB6320AB6322AB6324AB6418AB6420AB6422AB6424AB6522AB6524AB6A18AB6A20AB6A22AB6A24AB6C18AB6C20AB6C22and AB6C24
- Lot codes and dates
27 of 27 products
Products covered by this recall Model / number Product as published 3600040143377Device Reference Number AB6022, , Lot Numbers: 8884608, 9132241, 9213522, 9396680, 9404775, 9495823, 9495824 3600040143506Device Reference Number AB6024, , Lot Numbers: 8156931, 8865281, 9102857, 9453594 3600040143636Device Reference Number AB6118, , Lot Numbers: 8691180 3600040143728Device Reference Number AB6120, , Lot Numbers: 8839916, 9090719, 9112199, 9177734, 9622870, 9690290 3600040143810Device Reference Number AB6122, , Lot Numbers: 7562886, 7562887 3600040143902Device Reference Number AB6124, , Lot Numbers: 7396107, 9102869, 9429206 3600040144046Device Reference Number AB6220, , Lot Numbers: 8460192, 8529285 3600040144091Device Reference Number AB6222, , Lot Numbers: 8442243, 8459924, 8529346, 8592925, 8806400 3600040144145Device Reference Number AB6224, , Lot Numbers: 8442214, 8559578, 9112300 3600040144190Device Reference Number AB6318, , Lot Numbers: 7637490, 7670546, 8484834, 8498250, 8529294, 8529295 3600040144329Device Reference Number AB6320, , 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 3600040144459Device Reference Number AB6322, , Lot Numbers: 7338758, 7350593, 7713988, 7727275, 7727278, 7968373, 7977166, 7998276, 8008140, 8087091, 8255376, 8385860, 8506852, 8572895, 8749880, 8884710, 8931589, 8948207, 9031577, 9055067, 9077790, 9102922, 9282729, 9316049, 9342015, 9390309, 9863033, 9888907, 9899174, 9920693, 9920694 3600040144589Device Reference Number AB6324, , Lot Numbers: 7161442, 7187947, 7427129, 7494289, 7704381, 7727266, 7959383, 7959384, 7959385, 8008223, 8097934, 8097935, 8097937, 8341187, 8484780, 8484784, 8519827, 8608136, 8742649, 8884484, 8884485, 8923570, 8923572, 9008605, 9053873, 9102865, 9132280, 9261342, 9342043, 9342044, 9375106, 9429327, 9553583, 9571012, 9666667, 9683032 3600040144718Device Reference Number AB6418, , Lot Numbers: 8679531 3600040144787Device Reference Number AB6420, , Lot Numbers: 8749847 3600040144855Device Reference Number AB6422, , Lot Numbers: 8030359, 9192331, 9404762 3600040144923Device Reference Number AB6424, , Lot Numbers: 8050720, 9053872, 9843641 3600040145135Device Reference Number AB6522, , Lot Numbers: 9700704 3600040145203Device Reference Number AB6524, , Lot Numbers: 7606773 3600040145838Device Reference Number AB6A18, , Lot Numbers: 7387183, 7416523, 7447569, 7504520, 7969002, 8484935, 8593017, 8691164, 8839744, 8865285, 8884610, 8996730, 9090499, 9090500, 9201866, 9201868, 9351867, 9351868, 9778587, 9888888 - Amount recalled
- 36,369 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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