Coloplast Manufacturing US, LLC recalls X-Flow prostatectomy catheter
Reason for recall
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
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.
Lot / code information
- GTIN
- 3600040143377
- Lot #
- 8884608, 9132241, 9213522, 9396680, 9404775, 9495823, 9495824 ; Device Reference Number AB6024
- GTIN
- 3600040143506
- Lot #
- 8156931, 8865281, 9102857, 9453594 ; Device Reference Number AB6118
- GTIN
- 3600040143636
- Lot #
- 8691180; Device Reference Number AB6120
- GTIN
- 3600040143728
- Lot #
- 8839916, 9090719, 9112199, 9177734, 9622870, 9690290 ; Device Reference Number AB6122
- GTIN
- 3600040143810
- Lot #
- 7562886, 7562887; Device Reference Number AB6124
- GTIN
- 3600040143902
- Lot #
- 7396107, 9102869, 9429206 ; Device Reference Number AB6220
- GTIN
- 3600040144046
- Lot #
- 8460192, 8529285; Device Reference Number AB6222
- GTIN
- 3600040144091
- Lot #
- 8442243, 8459924, 8529346, 8592925, 8806400; Device Reference Number AB6224
- GTIN
- 3600040144145
- Lot #
- 8442214, 8559578, 9112300 ; Device Reference Number AB6318
- GTIN
- 3600040144190
- Lot #
- 7637490, 7670546, 8484834, 8498250, 8529294, 8529295 ; Device Reference Number AB6320
- GTIN
- 3600040144329
- Lot #
7416561, 8030228, 8268284, 8296927, 8296928, 8296931 — +31 moreShow all
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 #
7338758, 7350593, 7713988, 7727275, 7727278, 7968373 — +25 moreShow all
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; Device Reference Number AB6324- GTIN
- 3600040144589
- Lot #
7161442, 7187947, 7427129, 7494289, 7704381, 7727266 — +30 moreShow all
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; Device Reference Number AB6418- GTIN
- 3600040144718
- Lot #
- 8679531; Device Reference Number AB6420
- GTIN
- 3600040144787
- Lot #
- 8749847; Device Reference Number AB6422
- GTIN
- 3600040144855
- Lot #
- 8030359, 9192331, 9404762; Device Reference Number AB6424
- GTIN
- 3600040144923
- Lot #
- 8050720, 9053872, 9843641 ; Device Reference Number AB6522
- GTIN
- 3600040145135
- Lot #
- 9700704; Device Reference Number AB6524
- GTIN
- 3600040145203
- Lot #
- 7606773; Device Reference Number AB6A18
- GTIN
- 3600040145838
- Lot #
7387183, 7416523, 7447569, 7504520, 7969002, 8484935 — +14 moreShow all
7387183, 7416523, 7447569, 7504520, 7969002, 8484935, 8593017, 8691164, 8839744, 8865285, 8884610, 8996730, 9090499, 9090500, 9201866, 9201868, 9351867, 9351868, 9778587, 9888888; Device Reference Number AB6A20- GTIN
- 3600040145906
- Lot #
7187871, 7238887, 7326866, 7405932, 7487264, 7646979 — +30 moreShow all
7187871, 7238887, 7326866, 7405932, 7487264, 7646979, 7646980, 7694201, 8519729, 8519730, 8592981, 8656316, 8749861, 8765663, 8829366, 8853825, 8865362, 8911324, 8911325, 8931643, 8997524, 8997525, 9031251, 9159893, 9159894, 9177746, 9351843, 9362261, 9374229, 9419454, 9445814, 9472372, 9540992, 9558678, 9558679, 9558680 ; Device Reference Number AB6A22- GTIN
- 3600040145975
- Lot #
7171321, 7290540, 7338690, 7350471, 7440879, 7469993 — +51 moreShow all
7171321, 7290540, 7338690, 7350471, 7440879, 7469993, 7469995, 7469996, 7504590, 7516900, 7680717, 7694159, 7773602, 7810082, 7948506, 7968353, 7998159, 8008112, 8008113, 8097918, 8111866, 8289277, 8289280, 8289282, 8459856, 8529306, 8529307, 8529308, 8608132, 8765655, 8806462, 8839832, 8839833, 8839835, 8865393, 8865394, 8923543, 8923544, 8996594, 8996596, 9008485, 9019036, 9031180, 9031191, 9055054, 9201841, 9240207, 9282369, 9294592, 9461963, 9461964, 9472329, 9505126, 9558646, 9817372, 9829430, 9849265 ; Device Reference Number AB6A24- GTIN
- 3600040146040
- Lot #
7362278, 7362280, 7387201, 7469990, 7504565, 7694210 — +19 moreShow all
7362278, 7362280, 7387201, 7469990, 7504565, 7694210, 7714088, 8111864, 8255345, 8350315, 8498243, 8603744, 8742657, 8765683, 8853712, 8865439, 9031093, 9041479, 9159898, 9177566, 9374196, 9374197, 9385383, 9446056, 9937345 ; Device Reference Number AB6C18- GTIN
- 3600040146316
- Lot #
- 8418135, 9683014 ; Device Reference Number AB6C20
- GTIN
- 3600040146361
- Lot #
- 7908260, 8268412, 8350306, 8408126, 8529315 ; Device Reference Number AB6C22
- GTIN
- 3600040146415
- Lot #
- 8559519, 8619991, 8656312, 8691203, 8829379, 9018625, 9141394, 9374181 ; Device Reference Number AB6C24
- GTIN
- 3600040146460
- Lot #
- 9634480
Show 44 more code fieldsShow fewer
What the firm is doing
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.
DistributionShow detailsHide
US Nationwide. Canada.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0845-2025
- FDA 510(k) clearance · K013172The device's official FDA premarket clearance record
- FDA device classification · EZLOfficial FDA classification for this device type
- CFR regulation · 21 CFR 876.5130The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Coloplast Manufacturing US, LLCSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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