Recall archive / FDA device enforcement
stryker Sage PrimaFit External Urine Management System for the Female Anatomy — FDA record Z-0356-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 23, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- stryker Sage PrimaFit External Urine Management System for the Female Anatomy
- Reason
- 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
- Classification
- Class II
- Recalling firm
- Sage Products Inc
- Quantity
- 174,960 devices
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0356-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | GTIN 00618029600417, Lot Codes: 93667, 93614, 93613 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US and Canada
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Nov 29, 2023
- Recall initiation date
- Oct 23, 2023
- Center classification date
- Nov 20, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.