Reported Nov 29, 2023 · Ongoing
stryker Sage PrimaFit External Urine Management System for the Female Anatomy
Sage Products Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sage Products Inc · 3909 3 Oaks Rd · Cary, IL · 60013-1804
Is this the product you have?
- stryker Sage PrimaFit External Urine Management System for the Female Anatomy
- Lot codes and dates
- GTIN 00618029600417
- Lot Codes
936679361493613
- Amount recalled
- 174,960 devices
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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