Device Recall RUSCH

  • 모델명 / 제조번호(시리얼번호)
    Catalogue number: 76816, Lot number 0J005.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution: AZ, CA, FL, GA, IL, KS, KY, LA, MA, MS, NC, NJ, NM, NY, OH, OK, PA, TN, TX, VA, WI including Puerto Rico.
  • 제품 설명
    ***** EXPANDED RECALL ***** || Rusch Foley Catheter Insertion Tray with Preconnected Bag and 16 Fr. Catheter, Manufactured for and distributed by Teleflex Medical, Research Triangle Park, NC 57708 || Product Usage: For one time use per the Directions for Use with urinary catheter for drainage of urine.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Teleflex Medical, 4024 Stirrup Creek Dr, Durham NC 27703-9000
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 37 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    product number RLA-142-3, lot 002990-6, exp. 2007/03 and lot 002990-7, exp. 2007/02; the recall was expanded on 11/15/05 to include lot numbers 004622-3 and 004622-4
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide
  • 제품 설명
    Rusch/MMG Urinary Catheterization System, 14 Fr; the single use sterile kit contains a Rusch/MMG Intermittent Catheter, gauze tissue, povidone iodine swabs, two vinyl gloves and underpad; 100 kits per box; Rusch, 2450 Meadowbrook Pwy, Duluth, GA 30096, Assembled in Mexico from U.S. Components; product number RLA-142-3
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Catalogue number: 390060, Lot number: 20100515 & 20100501; Catalogue number: 452919, Lot number: 20100405.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution: AZ, CA, FL, GA, IL, KS, KY, LA, MA, MS, NC, NJ, NM, NY, OH, OK, PA, TN, TX, VA, WI including Puerto Rico.
  • 제품 설명
    RUSCH Urinary Drainage Bag, 2000 ml || Product Usage: For one time use per the Directions for Use with urinary catheter for drainage of urine.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Catalog number: A1300VA, Lot number: 02E1002552   Catalog number: A1300, Lot number: 02F1001467, 02F1002271, 02F1003283, 02G1000845 and 02G1001302.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution (USA) including the states of FL, GA, OH and SC.
  • 제품 설명
    Rusch, Sure Seal Golden Drain, One Piece Urinary Incontinence Device, Teleflex Medical. || Used for urine collection.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Product number: 238500220, Lot numbers: 108305, 140250, 142683, 153802, 276286, 359988, 370083, 375047 and 378586.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution and (USA) Nationwide Distribution.
  • 제품 설명
    RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 22 Fr. 40 cm, Distributed by Teleflex Medical, Research Triangle Park, NC. || Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Product Number: 238300080, Lot Numbers: 082827-1, 120007, 122274, 122275, 123171, 124446, 129582, 130627, 142572, 318007, 322167, 335514,338383, 340211, 342044, 350053, 350054, 350055, 359272, 359989 and 405523.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution and (USA) Nationwide Distribution.
  • 제품 설명
    RUSCH, GB: Female Catheter, All Purpose PVC, 08 Fr. 18 cm, Distributed by Teleflex Medical, Research Triangle Park, NC || Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract.
  • Manufacturer
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