Z-1485-2017Class II

PureWick External Catheter for Women-Wick

Name: Z-1485-2017 PureWick External Catheter for Women-Wick
Creator: Purewick Corporation
Published: 2016-02-24
License: https://open.fda.gov/license/

Purewick Corporation / initiated 2016-02-24 / Terminated / root cause: labeling and UDI

FDA source

Purewick Corporation began a recall of PureWick External Catheter for Women-Wick Product Usage: A flexible, contoured external catheter (a Wick) is positioned between the labia and gluteus muscles... on 2016-02-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1485-2017
Classification: Class II
Status: Terminated
Initiated: 2016-02-24
Posted: 2017-03-06
Terminated: 2017-05-09
Recalling firm: Purewick Corporation
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).
Product code: NNW Bag, Urine Collection, Leg, For External Use, Non-Sterile
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
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 [email protected]. 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.
Quantity in commerce: 176,863 units
Distribution: US: Nationwide Distribution
Product codes and lots: Item # 625

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1485-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1485-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-18

Product code NNW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)