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U.S. Department of Health and Human Services

Class 2 Device Recall stryker Sage PrimaFit

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  Class 2 Device Recall stryker Sage PrimaFit see related information
Date Initiated by Firm October 23, 2023
Date Posted November 21, 2023
Recall Status1 Open3, Classified
Recall Number Z-0356-2024
Recall Event ID 93229
Product Classification Collector, urine, powered, non indwelling catheter - Product Code NZU
Product stryker Sage PrimaFit External Urine Management System for the Female Anatomy
Code Information GTIN 00618029600417, Lot Codes: 93667, 93614, 93613
Recalling Firm/
Manufacturer		 Sage Products Inc
3909 3 Oaks Rd
Cary IL 60013-1804
For Additional Information Contact
800-421-6556
Manufacturer 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
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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