Exact FDA event identifier

Event 93229

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

Open FDA event record

Event summary

Timeline bucket: October 23, 2023
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Sage Products Inc

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.

How coverage and grouping work

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

stryker Sage PrimaFit External Urine Management System for the Female Anatomy

Z-0356-2024

Recall number: Z-0356-2024
Initiated: October 23, 2023
Classification: Class II
Status: Ongoing
Recalling firm: Sage Products Inc
Quantity: 174,960 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

A small percentage of devices in three lots of product may contain a tape with a natural rubber latex adhesive which is not declared on the label

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A small percentage of devices in three lots of product may contain a tape with a natural rubber latex adhesive which is not declared on the label

Code information

GTIN 00618029600417, Lot Codes: 93667, 93614, 93613

Distribution pattern

US and Canada