stryker Sage PrimaFit External Urine Management System for the Female Anatomy
Recall
- Recall Number
- Z-0356-2024
- Event Number
- 93229
- Firm
- Sage Products Inc 3909 3 Oaks Rd Cary IL 60013-1804
- FEI Number
- 1419181
- Product Code
- NZU
- Status
- Open, Classified
- Root Cause
- Process change control
- Initiated
- October 23, 2023
- Posted
- November 21, 2023
Description
stryker Sage PrimaFit External Urine Management System for the Female Anatomy
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
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.
US and Canada
174,960 devices