Sage Products Inc recalls stryker Sage PrimaFit External Urine Management System for the Female Anatomy
- Recall date
- October 23, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0356-2024
- FDA classification
- Class II
- Brand / firm
- Sage Products Inc
- Sold / distributed
- US and Canada
Why it was recalled
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
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
stryker Sage PrimaFit External Urine Management System for the Female Anatomy
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