Sage PrimaFit Urine Management (Sage) – undeclared latex (2023)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
stryker Sage PrimaFit External Urine Management System for the Female Anatomy
Brand
Sage Products Inc 3909 3 Oaks Rd Cary IL 60013-1804
Lot Codes / Batch Numbers
GTIN 00618029600417, Lot Codes: 93667, 93614, 93613
Products Sold
GTIN 00618029600417, Lot Codes: 93667, 93614, 93613
Sage Products Inc 3909 3 Oaks Rd Cary IL 60013-1804 is recalling stryker Sage PrimaFit External Urine Management System for the Female Anatomy due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
Stryker issued an URGENT MEDICAL DEVICE CORRECTION NOTICE to its consignees on 10/23/2023 via USPS Certified Mail. The notice explained the issue and the potential risk to user and requested the following actions: 1. Locate the product listed above and if tape is detected on the product once the product is opened, do not use on patients that have a latex allergy. Isolate and discard any impacted product with tape to avoid accidental use by a patient with a latex sensitivity. 2. Distribute this notice to all hospital staff that need to be aware of the problem with this device. 3. Maintain awareness of this communication internally by placing this notice at the point where the product is stored prior to use. 4. Inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients appropriately. Additional action for distributors only: 1. Locate the product listed above in your inventory and attach a provided label to the side to each case of the impacted product to ensure that the End User will be made aware of this issue.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026