WELCON Catheterization Tray 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Nurse Assist, Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    60412
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0502-2012
  • 사례 시작날짜
    2011-09-02
  • 사례 출판 날짜
    2012-01-11
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-10-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Catheter, urological - Product Code KOD
  • 원인
    Nurse assist, inc. received a recall notice from the triad group. this recall has been initiated due to a recall of the pvp solution packs manufactured by the triad group that are contained in certain procedure trays.
  • 조치
    Nurse Assist sent a recall notice dated September 2, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory immediately and quarantine the affected product. Customers were also instructed to identify their customers and notify them at once of the product recall. Customers were instructed to complete and return the enclosed response form as soon as possible. For those distributors that choose to destroy the affected product they must use the attached Notice of Destruction to report the specifics of the destroyed product. and contact Nurse Assist Customer Service for a RGA # prior to destruction. For any questions call Nurse Assist Customer Service at 1-800-649-6800.

Device

  • 모델명 / 제조번호(시리얼번호)
    Assembly ID UT70101002U and UT70101400U. Lot Numbers: 905184 (1999116), 905240 (2013784), 905306 (2022227), 906320 (2050130), 906326 (2050141), 907177 (2075692), 907229 (2079816), 909270 (2152734), 910007 (2165988), 910224 (2183856), 911074 (2205933), 912006 (2242897), 912245 (2265322), 1001328 (2299790), 1002197 (2324937), 1002350 (2342704), 1003055 (2346521), 1003163 (2362102), 1003337 (2376018), 1004331 (2412783), 1005322 (2447048), 1006195 (2473260), 1007028 (2494621), 1007132 (2505492), 1007365 (2521813), 1007374 (2521824), 1008200 (2521842), 1008272 (2548567), 1010125 (2609442), 1010211 (2619061), 1010379 (2635683), 1011117 (2653292), 1011242 (2662145), 905179 (1999111), 905304 (2022225), 906031 (2024204), 906034 (2024207), 906223 (2045289), 906317 (2050127), 906322 (2050137), 907174 (2075689), 907224 (2079809), 907410 (2096921), 909321 (2155644), 910002 (2165983), 910217 (2183849), 910315 (2193854), 910405 (2197500), 911071 (2205929), 911272 (2225075),912004 (2242895), 912242 (2265319), 912357 (2270548), 1001032 (2272542), 1001122 (2282233), 1001325 (2299787), 1002031 (2308780), 1002192 (2324932), 1002262 (2332074), 1002348 (2342702), 1003049 (2346515), 1003161 (2362100), 1003276 (2371680), 1003329 (2375786), 1003334 (2376015), 1003340 (2376022), 1004239 (2399012), 1004326 (2412777), 1005001 (2421350), 1005176 (2434535), 1005318 (2447043), 1006068 (2456705), 1006106 (2463036), 1006190 (2473255), 1006315 (2480387), 1007021 (2494612), 1007128 (2505486), 1007363 (2521808), 1007370 (2521819), 1008019 (2521827), 1008195 (2521834), 1009017 (2555280), 1009280 (2592199), 1009383 (2600148), 1010123 (2609440), 1010206 (2619056), 1010377 (2635681), 1011076 (2644159), 1011114 (2653289).   Pack Lot #s: 35207, 35317, 35560, 35853, 35995, 36146, 36302, 36467, 36614, 36763, 36903, 37026, 37162, 37273, 37400, 37673, 37807, 35207 35317, 35560, 35853,35995, 35995-36146, 36146, 36302, 36467, 36614, 36763, 36614, 36614/36763, 36763, 36903, 37026, 37162, 37273, 37400, 37673, 37807.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Canada and Saudi Arabia.
  • 제품 설명
    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 Manufactured for: Coloplast A/S 3050 Denmark STERILE EO Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 Distribue par: Coloplast Canada Corporation 3300 Ridgeway Drive Unit 12 Mississauga, Ontario Canada L5L 5Z9 1-905-820-7588 || Catheter Insertion Tray 10cc Pre-Filled Syringe with PVP Swabs
  • Manufacturer

Manufacturer

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