Events

Recall of Device Recall PureWick External Catheter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Purewick Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76571
  • Event Risk Class
    Class 2
  • Event Number
    Z-1485-2017
  • Event Initiated Date
    2016-02-24
  • Event Date Posted
    2017-03-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153554
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Bag, urine collection, leg, for external use, non-sterile - Product Code NNW
  • Reason
    Purewick is recalling external catheter for women wicks because the labeling did not contain the phrase "this product contains dry natural rubber" and/or erroneously included the phrase "latex-free." the white gauze component of the purewick contains dry natural rubber.
  • Action
    A Urgent Medical Device recall letter dated March 2, 2017 will be sent to customers to inform them that PureWick Corporation is recalling specific lots of PureWick external catheter for women Wicks, Item #625. Customers are informed that PureWick is recalling PureWick Wicks because labeling on product shipped prior to February 22, 2017 either did not contain the phrase This product contains dry natural rubber and/or erroneously included the phrase Latex-free. The white gauze component of the PureWick Wick contains dry natural rubber. PureWick Corporation has received zero complaints or reports of adverse events related to the error in labeling. Customers are informed of the risk to health and the actions to be taken. Customers are instructed to complete the enclosed PureWick Field Correction form and fax to PureWick Corporation at (619) 660-5459 or email to response@purewick.com. Customers with questions or would like assistance completing the PureWick Field Correction Form are instructed to call PureWick toll-free at (844) 584-0734 Monday  Friday from 8:00 a.m. to 4:30 p.m., Pacific Time.

Device

Device Recall PureWick External Catheter
  • Model / Serial
    Item # 625
  • Product Classification
    Gastroenterology-Urology Devices
  • 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
    Purewick Corporation

Manufacturer

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