Purewick Corporation: Medical Device Recall in 2017 - (Recall #: Z-1485-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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).

Product Classification:

Class II

Date Initiated: February 24, 2016

Date Posted: March 29, 2017

Recall Number: Z-1485-2017

Event ID: 76571

Reason for Recall:

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.

Status: Terminated

Product Quantity: 176,863 units

Code Information:

Item # 625

Distribution Pattern:

US: Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated