stryker Sage PrimaFit External Urine Management System for the Female Anatomy
Summary
The FDA issued a Class II for stryker Sage PrimaFit External Urine Management System for the Female Anatomy by Sage Products Inc. 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.
Details
Source
Device Recall
External ID
Z-0356-2024
Action Date
2023-11-29
Status
Ongoing
Category
device
Product Description
stryker Sage PrimaFit External Urine Management System for the Female Anatomy
Lot/Code Info: GTIN 00618029600417, Lot Codes: 93667, 93614, 93613
Quantity Affected: 174,960 devices
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
Distribution
US and Canada
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-23
Company
Cary, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 167 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Sage Products Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Sage Products Inc have FDA actions?
This is the only FDA action we have on record for Sage Products Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0356-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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