PureWick External Catheter for Women-Wick Product Usage: A flexible — Class II medical device recall Z-1485-2017
Terminated recall by Purewick Corporation, reported 2017-03-29, distributed nationwide. PureWick is recalling external catheter for women Wicks because the labeling did not contain the phrase "This
| Recall number | Z-1485-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Purewick Corporation, El Cajon, CA, United States |
| Recall initiated | 2016-02-24 |
| Classified | 2017-03-18 |
| Reported by FDA | 2017-03-29 |
| Terminated | 2017-05-09 |
| Distributed | Nationwide (US) |
| Quantity | 176,863 units |
| Reason classes | labeling |
| Model numbers | 625 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1485-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.