Device Recall PureWick External Catheter

  • Model / Serial
    Item # 625
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US: Nationwide Distribution
  • Product Description
    PureWick External Catheter for Women-Wick || Product Usage: || A flexible, contoured external catheter (a Wick) is positioned between the labia and gluteus muscles. The function of the Wick is to draw urine away from the body through the Wick to a storage container away from the body through a PVC tube via a continuous, low pressure vacuum pump (PureWick DryDoc) or to a hospital wall vacuum. There is never a reversal of flow direction or static state of fluid between the device and the patient. Also, the dry natural rubber component is double wrapped with 75D polyester and it is not stretched in its application to expose bare rubber to a user. The Wick does not enter the vagina (Figure 1).
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Purewick Corporation, 2030 Gillespie Way Ste 109, El Cajon CA 92020-0910
  • Manufacturer Parent Company (2017)
  • Source
    USFDA