Device Recall TORAY

  • Model / Serial
    540204R001
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution and in the state of TX
  • Product Description
    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

Manufacturer

  • Manufacturer Address
    Convatec Inc., 200 Headquarters Park Dr, Skillman NJ 08558-2600
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

4 devices with a similar name

Learn more about the data here

  • Model / Serial
    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.)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    California, New Jersey, Florida, Texas, Ohio, Wisconsin, New York, and Washington.
  • Product Description
    Hollow Fiber Dialyzer Model FILTRYZER B1-1.3H
  • Manufacturer
  • Model / Serial
    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.)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    California, New Jersey, Florida, Texas, Ohio, Wisconsin, New York, and Washington.
  • Product Description
    Hollow Fiber Dialyzer Model FILTRYZER B3-1.0A, B3 -1.3A, and B3-1.6a
  • Manufacturer
  • Model / Serial
    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.)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    California, New Jersey, Florida, Texas, Ohio, Wisconsin, New York, and Washington.
  • Product Description
    Hollow Fiber Dialyzer, Model FILTRYZER BK-2.IU
  • Manufacturer
  • Model / Serial
    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.)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    California, New Jersey, Florida, Texas, Ohio, Wisconsin, New York, and Washington.
  • Product Description
    Hollow Fiber Dialyzer, Model TORAYSULFONE BS-1.6, and BS-1.8
  • Manufacturer