FDA recall Z-0356-2024

Sage Products Inc · Class II · device

Product

stryker Sage PrimaFit External Urine Management System for the Female Anatomy

Reason for recall

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

Distribution

US and Canada

Key facts

Status
Ongoing
Initiation date
2023-10-23
Report date
2023-11-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cary, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0356-2024