FDAFDA · Food and drugs·Recall number Z-0356-2024
stryker Sage PrimaFit External Urine Management System for the Female Anatomy
Published November 29, 2023 · Recall initiated: October 23, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sage Products Inc
- Distributor
- US and Canada
- Lot
- GTIN 00618029600417, Lot Codes: 93667, 93614, 93613
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.