Coloplast Manufacturing US, LLC Recall 95895
Description: 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.
Coloplast Manufacturing US, LLC Recall 95895 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0845-2025 |
| Event ID | 95895 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | US Nationwide. Canada. |
| Quantity | 36,369 units |
| Recall Reason | A possible sterility issue was detected in Coloplast's facility on some Coloplast products. |
| Device Classification | 20250122 |
| Device Code Info | 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, 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 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; Device Reference Number AB6418, GTIN 3600040144718, Lot Numbers: 8679531; Device Reference Number AB6420, GTIN 3600040144787, Lot Numbers: 8749847; Device Reference Number AB6422, GTIN 3600040144855, Lot Numbers: 8030359, 9192331, 9404762; Device Reference Number AB6424, GTIN 3600040144923, Lot Numbers: 8050720, 9053872, 9843641 ; Device Reference Number AB6522, GTIN 3600040145135, Lot Numbers: 9700704; Device Reference Number AB6524, GTIN 3600040145203, Lot Numbers: 7606773; Device Reference Number AB6A18, GTIN 3600040145838, Lot Numbers: 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 Numbers: 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 Numbers: 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 Numbers: 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 Numbers: 8418135, 9683014 ; Device Reference Number AB6C20, GTIN 3600040146361, Lot Numbers:7908260, 8268412, 8350306, 8408126, 8529315 ; Device Reference Number AB6C22, GTIN 3600040146415, Lot Numbers: 8559519, 8619991, 8656312, 8691203, 8829379, 9018625, 9141394, 9374181 ; Device Reference Number AB6C24, GTIN 3600040146460, Lot Numbers: 9634480; |
| Center Classification Date | 20250110 |
| Recall Initiation Date | 20241202 |
| Recalling Firm | Coloplast Manufacturing US, LLC |
| Initial Notification | Letter |
| Similar To |