Devices

Device Recall CystoCare Coloplast

  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai and Saudi Arabia.
  • 제품 설명
    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
    Nurse Assist, Inc
  • 1 Event

제조사

Nurse Assist, Inc
  • 제조사 주소
    Nurse Assist, Inc, 3400 Northern Cross Blvd, Fort Worth TX 76137-3600
  • 제조사 모회사 (2017)
    Nurse Assist Inc.
  • Source
    USFDA

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Device Recall CystoCare Coloplast
  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai and Saudi Arabia.
  • 제품 설명
    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
    Nurse Assist, Inc
Device Recall CystoCare Coloplast
  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai and Saudi Arabia.
  • 제품 설명
    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
    Nurse Assist, Inc
Device Recall CystoCare Coloplast
  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai and Saudi Arabia.
  • 제품 설명
    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
    Nurse Assist, Inc
Device Recall CystoCare Coloplast
  • 모델명 / 제조번호(시리얼번호)
    Lot Codes: 1002195, 1003278, 1005179, 1006193, 1007024, 1008271, 1009282, 1010209, 806074, 806277, 902050, 903224, 905182, 906325, 909173, 910005, 911274, and 912244.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai and Saudi Arabia.
  • 제품 설명
    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
    Nurse Assist, Inc
Device Recall CystoCare Coloplast
  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai and Saudi Arabia.
  • 제품 설명
    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
    Nurse Assist, Inc
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