Recall Z-0356-2024 ยท NZU Collector, Urine, Powered, Non Indwelling Catheter
Sage Products Inc
stryker Sage PrimaFit External Urine Management System for the Female Anatomy
| Date | Nov 21, 2023 (initiated Oct 23, 2023) |
| Status | Open, Classified |
| 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 |
| Root cause | Process change control |
| Action | 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 a |
| Quantity | 174,960 devices |
| Distribution | US and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.