Device Recall CystoCare Coloplast

  • Model / Serial
    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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai and Saudi Arabia.
  • Product Description
    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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Nurse Assist, Inc, 3400 Northern Cross Blvd, Fort Worth TX 76137-3600
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

8 devices with a similar name

Learn more about the data here

  • Model / Serial
    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
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai and Saudi Arabia.
  • Product Description
    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
  • Manufacturer
  • Model / Serial
    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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai and Saudi Arabia.
  • Product Description
    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.
  • Manufacturer
  • Model / Serial
    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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai and Saudi Arabia.
  • Product Description
    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.
  • Manufacturer
  • Model / Serial
    Lot Codes: 1002195, 1003278, 1005179, 1006193, 1007024, 1008271, 1009282, 1010209, 806074, 806277, 902050, 903224, 905182, 906325, 909173, 910005, 911274, and 912244.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai and Saudi Arabia.
  • Product Description
    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.
  • Manufacturer
  • Model / Serial
    Lot Codes:1002198, 1006070, 1007367, 1010126, 806278, 809071, 1001327, 1002033, 1002196, 1002265, 1003052, 1003279, 1003331, 1003343, 1004241, 1004328, 1005004, 1005180, 1005321, 1006318, 1007025, 1008022, 1008198, 806075, 806124, 806208, 806279, 902051, 902314, 904044, 904353, 905183, 905305, 906033, 906037, 906224, 907176, 907227, 908149, 908346, 909174, 909269, 910220, and 910407.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai and Saudi Arabia.
  • Product Description
    Case Label: UT8140 Urethral Insertion Tray 14 Fr Nelaton PVC Catheter 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: UT8140 Urethral Insertion Tray 14 Fr Nelaton PVC Catheter with PVP Swabs Contents 1200 cc graduated drainage tray Waterproof underpad Fenestrated drape Vinyl gloves (2) cuffed Lubricating jelly Specimen container with ID label 14 Fr. PVC Nelaton catheter 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.
  • Manufacturer
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