Device product

stryker Sage PrimaFit External Urine Management System for the Female Anatomy

Z-0356-2024

October 23, 2023

Class II

Product summary

Firm: Sage Products Inc
Event: Event 93229
Status: Ongoing
Classification: Class II
Quantity: 174,960 devices
Official record key: device-enforcement:Z-0356-2024

Official wording

Reason: 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

Code information: GTIN 00618029600417, Lot Codes: 93667, 93614, 93613

Distribution pattern: US and Canada

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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