Device Recall CystoCare Coloplast

Lot Code:1005181, 1006194, 807109, 809068, 904354, 1001121, 1002030, 1002191, 1003160, 1003274, 1003333, 1003339, 1004238, 1004324, 1005175, 1005317, 1006067, 1006189, 1006314, 806272, 807110, 808202, 901126, 902046, 902225, 902239, 903068, 903220, 903326, 904349, 905178, 906316, 906321, 907223, 907409, 909169, 910001, 910215, 910314, 911070, 912002, 912149, 912241, and 912355

Gastroenterology-Urology Devices

2

No

Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai and Saudi Arabia.

Case Label: REF UT1002 Irrigation Tray with 60 cc Piston Syringe Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark STERILE EO Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 || Tray Label: Cysto-Care Coloplast Irrigation Tray with 60 cc Piston Syringe Contents 1200 cc graduated drainage tray 500 cc graduated container 60 cc piston syringe Waterproof underpad Alcohol wipe For Rx Only Sterile Unless package is damaged or opened. Latex Free REF: UT1002 Manufactured for: Coloplast A/S 3050 Denmark Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 STERILE EO Assembled in USA || Intended use: The trays are irrigation trays for catheters

Lot Codes: 1001328, 1002197, 1002350, 1003055, 1003163, 1003337, 1004331, 1005322, 1006195, 1007028, 1007365, 1007374, 1008200, 1008272, 1009075, 1009178, 1010125, 1010211, 1010379, 1011117, 1011242, 807112, 809069, 812218, 901113, 901210, 901259, 902054, 903070, 904212, 904355, 905184, 905240, 905306, 906320, 906326, 907177, 907229, 908269, 909176, 909270, 910007, 910224, 911074, 912006, 912245, 1001032, 1001122, 1001325, 1002031, 1002192, 1002262, 1002348, 1003049, 1003161, 1003276, 1003329, 1003334, 1003340, 1004239, 1004326, 1005001, 1005176, 1005318, 1006068, 1006106, 1006190, 1006315, 1007021, 1007363, 1007370, 1008019, 1008195, 1009017, 1009070, 1009094, 1009175, 1009280, 1009383, 1010123, 1010206, 1010377, 1011076, 1011114, 806070, 806205, 806274, 901127, 901206, 901257, 902047, 902226, 902312, 903160, 903221, 903327, 904042, 904350, 904375, 905073, 905179, 905304, 906031, 906034, 906223, 906317, 906322, 907174, 907224, 907410, 908147, 908234, 908265, 908344, 909170, 909266, 909321, 910002, 910217, 910315, 910405, 911071, 911272, 912004, 912150, 912242, and 912357.

Gastroenterology-Urology Devices

2

No

Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai and Saudi Arabia.

Case Label: REF UT7010 Catheter Insertion Tray 10cc Pre-Filled Syringe with PVP Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free STERILE EO Manufactured for: Coloplast A/S 3050 Denmark Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 || Tray Label: Cysto-Care Coloplast REF: UT7010 Catheter Insertion Tray 10 cc Pre-Filled Syringe with PVP Swabs Contents 1200 cc graduated drainage tray Waterproof underpad Fenestrated drape Vinyl gloves (2) cuffed Lubricating jelly Specimen container with ID label 10 cc pre-filled syringe Swabsticks (3) PVP solution For Rx Only Sterile. Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 STERILE EO Assembled in USA || Intended use: The trays are urological catheter trays.

Lot Codes: 803131, 804053, 1001123, 1002193, 1002263, 1003050, 1003330, 1003335, 1003341, 1005002, 1005177, 1005319, 1006002, 1006069, 1006191, 1006316, 1007022, 1007371, 1008020, 1008196, 1008269, 1009018, 1009071, 1009176, 1009384, 1010207, 1011077, 1011115, 1011337, 806071, 806206, 806275, 809278, 811067, 812042, 812216, 901112, 901128, 901207, 902048, 902240, 903161, 903222, 903328, 904043, 904351, 905074, 905180, 905239, 906032, 906035, 906318, 906323, 907225, 908266, 909171, 909267, 909322, 910003, 910218, 910406, 911072, 911273, 912151, and 912358.

Gastroenterology-Urology Devices

2

No

Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai and Saudi Arabia.

Case Label: REF UT7015 Catheter Insertion Tray 10cc Pre-Filled Syringe with BZK Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free STERILE EO Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 Manufactured for: Coloplast A/S 3050 Denmark || Tray Label: Cysto-Care Coloplast REF: UT7015 Catheter Insertion Tray 10 cc Pre-Filled Syringe with BZK Swabs contents 1200 cc graduated drainage tray Waterproof underpad Fenestrated drape Vinyl gloves (2) cuffed Lubricating jelly Specimen container with ID label 10 cc pre-filled syringe Swabsticks (3) BZK solution For Rx Only. Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 STERILE EO Assembled in USA || Intended use: The trays are urological catheter trays.

Lot Codes: 1003280, 1004332, 1007366, 1009096, 1010239, 806072, 807115, 809070, 810232, 904045, 908150, 909325, 910225, 1001033, 1001124, 1001326, 1002032, 1002194, 1002264, 1002349, 1003051, 1003162, 1003277, 1003336, 1003342, 1004240, 1004327, 1005003, 1005178, 1005320, 1006192, 1006317, 1007023, 1007364, 1007372, 1008021, 1008197, 1008270, 1009019, 1009072, 1009095, 1009177, 1009281, 1009385, 1010124, 1010208, 1010238, 1010378, 1011078, 1011116, 1011241, 1011338, 806073, 806123, 806207, 806276, 807116, 807156, 809066, 809279, 811068, 811136, 812043, 812217, 901129, 901208, 901258, 902049, 902227, 902313, 903069, 903162, 903223, 903329, 904352, 905075, 905181, 906036, 906319, 906324, 907175, 907226, 907411, 908148, 908345, 909172, 909268, 909323, 910004, 910219, 910316, 911073, 912152, 912243, and 912359.

Gastroenterology-Urology Devices

2

No

Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai and Saudi Arabia.

Case Label: REF UT7030 Catheter Insertion Tray 30cc Pre-Filled Syringe with PVP Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free STERILE EO Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 Manufactured for: Coloplast A/S 3050 Denmark || Tray Label: Cysto-Care Coloplast REF: UT7030 Catheter Insertion Tray 30 cc Pre-Filled Syringe with PVP Swabs Contents 1200 cc graduated drainage tray Waterproof underpad Fenestrated drape Vinyl gloves (2) cuffed Lubricating jelly Specimen container with ID label 30 cc pre-filled syringe Swabsticks (3) PVP solution For Rx Only. Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 STERILE EO Assembled in USA || Intended use: The trays are urological catheter trays.

Lot Codes: 1002195, 1003278, 1005179, 1006193, 1007024, 1008271, 1009282, 1010209, 806074, 806277, 902050, 903224, 905182, 906325, 909173, 910005, 911274, and 912244.

Gastroenterology-Urology Devices

2

No

Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai and Saudi Arabia.

Case Label: REF UT7035 Catheter Insertion Tray 30cc Pre-Filled Syringe with BZK Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free STERILE EO Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 Manufactured for: Coloplast A/S 3050 Denmark || Tray Label: Cysto-Care Coloplast REF: UT7035 Catheter Insertion Tray 30 cc Pre-Filled Syringe with BZK Swabs Contents 1200 cc graduated drainage tray Waterproof underpad Fenestrated drape Vinyl gloves (2) cuffed Lubricating jelly Specimen container with ID label 30 cc pre-filled syringe Swabsticks (3) BZK solution For Rx Only Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 STERILE EO Assembled in USA || Intended use: The trays are urological catheter trays.