Purewick Corporation recalls PureWick External Catheter for Women-Wick Product Usage: A flexible, contoured external catheter (a Wick) is positioned…

Recall date

February 24, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1485-2017

FDA classification

Class II

Brand / firm

Purewick Corporation

Sold / distributed

US: Nationwide Distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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).