Medical device recalls Moderate risk

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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