Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 29, 2017
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. A
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 …
Purewick Corporation recalled PureWick External Catheter for Women-Wick Product Usage: A flexible, contoured exter… - a moderate-severity action.
PureWick External Catheter for Women-Wick Product Usage: A flexible, contoured exter… was recalled by Purewick Corporation in March 29, 2017. Reason: PureWick is recalling external catheter for women Wicks because the labeling did not contain the phrase "This…. Check the official notice for the remedy. Verify recall #Z-1485-2017 with the FDA Devices before acting.
The recall
Purewick Corporation issued this moderate-severity FDA Devices recall-PureWick is recalling external catheter for women Wicks because the labeling did not contain the phrase "This….
- Moderate
- severity level
- 177K units
- affected scope
- Class II
- classification
- March 29, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1485-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1485-2017) was formally reported on March 29, 2017, with the manufacturer initiating the action on February 24, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Purewick Corporation is listed as the recalling firm, operating out of El Cajon, CA. Federal records list the affected scope as 176,863 units, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: 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 co… Distribution data in the federal record shows the product reached: US: Nationwide Distribution. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
176,863 units
Related Recalls
6
3 from same agency
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).
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1485-2017 |
| Date reported | March 29, 2017 |
| Date initiated | February 24, 2016 |
| Recalling firm | Purewick Corporation |
| Firm location | El Cajon, CA |
| Affected scope | 176,863 units |
| Distribution | US: Nationwide Distribution |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1485-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product 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).. Recalled by Purewick Corporation. Units affected: 176,863 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 29, 2017. Severity: Moderate. Recall number: Z-1485-2017.
Where was the recalled product distributed? ▼
Distribution: US: Nationwide Distribution.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1485-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 29, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.