Recall Z-1485-2017— Purewick Corporation

Class II FDA medical device recall by Purewick Corporation, initiated 2016-02-24, terminated 2017-05-09. FDA's recall record names no specific 510(k) clearance for this event. Product: 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).. 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..

Recalling firm

Purewick Corporation

Classification

Class II

Status

Terminated

Initiated

2016-02-24

Terminated

2017-05-09

Firm location

El Cajon, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.