Device recall

Z-0356-2024: stryker Sage PrimaFit External Urine Management System for the Female Anatomy

FDA device recall · Class II · Sage Products Inc

Key facts

Recall number (Z-number) Z-0356-2024
Recall event 93229
Product stryker Sage PrimaFit External Urine Management System for the Female Anatomy
Product code NZU
Recalling firm Sage Products Inc
Recall class Class II
Status Open, Classified
FEI number 1419181

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)