stryker Sage PrimaFit External Urine Management System recall
stryker Sage PrimaFit External Urine Management System for the Female Anatomy
Why was stryker Sage PrimaFit External Urine Management System 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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN 00618029600417, Lot Codes: 93667, 93614, 93613
- Product
- stryker Sage PrimaFit External Urine Management System for the Female Anatomy
- Recalling firm
- Sage Products Inc
- Quantity
- 174,960 devices
- Distribution
- US and Canada
- Recall date
- November 29, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)