Z-0356-2024Class II

stryker Sage PrimaFit External Urine Management System for the Female Anatomy

Name: Z-0356-2024 stryker Sage PrimaFit External Urine Management System for the Female Anatomy
Creator: Sage Products Inc
Published: 2023-10-23
License: https://open.fda.gov/license/

Sage Products LLC / initiated 2023-10-23 / Open, Classified / root cause: labeling and UDI

FDA source

Sage Products Inc began a recall of stryker Sage PrimaFit External Urine Management System for the Female Anatomy on 2023-10-23. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0356-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-23
Posted: 2023-11-21
Recalling firm: Sage Products LLC
Product: stryker Sage PrimaFit External Urine Management System for the Female Anatomy
Product code: NZU Collector, Urine, Powered, Non Indwelling Catheter
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
Root cause tag: labeling and UDI
FDA 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 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.
Quantity in commerce: 174,960 devices
Distribution: US and Canada
Product codes and lots: GTIN 00618029600417, Lot Codes: 93667, 93614, 93613

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0356-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0356-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-29	2023-11-20

Product code NZU

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)