PlainRecalls
FDA Devices Moderate Class II Ongoing

stryker Sage PrimaFit External Urine Management System for the Female Anatomy

Reported: November 29, 2023 Initiated: October 23, 2023 #Z-0356-2024

Product Description

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

Details

Recalling Firm
Sage Products Inc
Units Affected
174,960 devices
Distribution
US and Canada
Location
Cary, IL

Frequently Asked Questions

What product was recalled?
stryker Sage PrimaFit External Urine Management System for the Female Anatomy. Recalled by Sage Products Inc. Units affected: 174,960 devices.
Why was this product 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
Which agency issued this recall?
This recall was issued by the FDA Devices on November 29, 2023. Severity: Moderate. Recall number: Z-0356-2024.