Device Recall TORAY

  • 모델명 / 제조번호(시리얼번호)
    540204R001
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution and in the state of TX
  • 제품 설명
    TORAY' Hydrocoat Foley Catheter || 12 x10 || 4.00 mm Fr x mL || Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Convatec Inc., 200 Headquarters Park Dr, Skillman NJ 08558-2600
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 4 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Lot 10830640 (All lot numbers having the last two digits ending in 40 or 41 and having the year of manufacture for individual units or sterilization date for cases from 01 on a unit and 2001 on to case to 03 and 2003. Expiry year dates are 04 or 2004 to 06 or 2006. An example date is 01 03 09 on a unit which is read 2001 March 09 and for the case with the same date an example would be 2001 03 09.)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    California, New Jersey, Florida, Texas, Ohio, Wisconsin, New York, and Washington.
  • 제품 설명
    Hollow Fiber Dialyzer Model FILTRYZER B1-1.3H
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: 10630840, 10230940, and 20230540.  (All lot numbers having the last two digits ending in 40 or 41 and having the year of manufacture for individual units or sterilization date for cases from 01 on a unit and 2001 on to case to 03 and 2003. Expiry year dates are 04 or 2004 to 06 or 2006. An example date is 01 03 09 on a unit which is read 2001 March 09 and for the case with the same date an example would be 2001 03 09.)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    California, New Jersey, Florida, Texas, Ohio, Wisconsin, New York, and Washington.
  • 제품 설명
    Hollow Fiber Dialyzer Model FILTRYZER B3-1.0A, B3 -1.3A, and B3-1.6a
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers 10531140, 11230940, 20121440, and 21230140. (All lot numbers having the last two digits ending in 40 or 41 and having the year of manufacture for individual units or sterilization date for cases from 01 on a unit and 2001 on to case to 03 and 2003. Expiry year dates are 04 or 2004 to 06 or 2006. An example date is 01 03 09 on a unit which is read 2001 March 09 and for the case with the same date an example would be 2001 03 09.)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    California, New Jersey, Florida, Texas, Ohio, Wisconsin, New York, and Washington.
  • 제품 설명
    Hollow Fiber Dialyzer, Model FILTRYZER BK-2.IU
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: 20310140, 20910540, and 20910541. (All lot numbers having the last two digits ending in 40 or 41 and having the year of manufacture for individual unit or sterilization date for cases from 01 on a unit and 2001 on to case to 03 and 2003. Expiry year dates are 04 or 2004 to 06 or 2006. An example date is 01 03 09 on a unit which is read 2001 March 09 and for the case with the same date an example would be 2001 03 09.)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    California, New Jersey, Florida, Texas, Ohio, Wisconsin, New York, and Washington.
  • 제품 설명
    Hollow Fiber Dialyzer, Model TORAYSULFONE BS-1.6, and BS-1.8
  • Manufacturer