Device Recall Unomedical

  • Model / Serial
    540204R001
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution and in the state of TX
  • Product Description
    SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/cc || 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
  • 2 Events

Manufacturer

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