FDA-Device2023-11-29Class II
stryker Sage PrimaFit External Urine Management System for the Female Anatomy
Sage Products Inc
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
Sold states
US and Canada
Affected count
174,960 devices
Manufactured in
3909 3 Oaks Rd, N/A, Cary, IL, United States
Products
stryker Sage PrimaFit External Urine Management System for the Female Anatomy
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0356-2024Don't want to check this manually?
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