Recall Z-0356-2024— Sage Products Inc
Class II · Ongoing
Class II FDA medical device recall by Sage Products Inc, initiated 2023-10-23. FDA's recall record names no specific 510(k) clearance for this event. Product: stryker Sage PrimaFit External Urine Management System for the Female Anatomy. 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.
- Recalling firm
- Sage Products Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-10-23
- Firm location
- Cary, IL, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.