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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76571

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
February 24, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Purewick Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

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Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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).

Z-1485-2017
Recall number
Z-1485-2017
Initiated
February 24, 2016
Classification
Class II
Status
Terminated
Recalling firm
Purewick Corporation
Quantity
176,863 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

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Inspect official wording and provenance

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.

Code information

Item # 625

Distribution pattern

US: Nationwide Distribution