stryker Sage PrimaFit External Urine Management System for the Female Anatomy
Class I - DangerousWhat Should You Do?
- Check if you have this product: GTIN 00618029600417, Lot Codes: 93667, 93614, 93613
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Sage Products Inc
- 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
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
stryker Sage PrimaFit External Urine Management System for the Female Anatomy
Product Codes/Lot Numbers:
GTIN 00618029600417, Lot Codes: 93667, 93614, 93613
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0356-2024
Related Recalls
A voluntary recall of a lot (67924) of Independent Care System due to the potential for damaged Sodium Bicarbonate Mouthpaste (cosmetic) tubes.
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products