Class 2 Device Recall AXS Universal Aspiration Tubing

• Date Initiated by Firm: December 02, 2020
• Create Date: April 27, 2021
• Recall Status: Terminated on June 17, 2024
• Recall Number: Z-1502-2021
• Recall Event ID: 87551
• 510(K)Number: K170329
• Product Classification: Pump, portable, aspiration (manual or powered) - Product Code BTA
• Product: Stryker Medela REF 077.0193 AXS Universal Aspiration Tubing (01)07612367053921 - Product Usage: AXS Universal Aspiration Tubing is used with the Dominant Flex Surgical Suction Pump.
• Code Information: Catalog Number: 077.0193 UDI Code: 07612367052719 Lot Number: W-024423
• FEI Number: 3002807523
• Recalling Firm/ Manufacturer: Medela AG Medical Technology; Lattichstrasse 4b; Baai Switzerland
• Manufacturer Reason for Recall: Incorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date should be "2021-07-24".
• FDA Determined Cause: Process control
• Action: On 12/01/2020, the firm sent an "Urgent Field Safety Notice" to customers informing them that the human readable shelf life is: 2023-07-24, whereas the barcode printed on the label shows the correct shelf life "2021-07-24." and that there is no risk to patient if the product is used prior to 2021-07-24. Beyond this date the shelf life is expired, and the sterility of these lots cannot be assured. Customers are instructed to: 1) Confirm that they received the Field Safety Notice by completing the Acknowledgement Form and Customer Response Form; 2) Removed from their inventory, put in quarantine and send back affected lots to their local distributor or confirm that they have destroyed affected lots. 3) Inform any health care professional with their organization that needs to be aware of the Field Safety Notice. For questions or additional assistance - vigilance@medela.ch
• Quantity in Commerce: 6,244 units
• Distribution: Worldwide distribution - U.S. Nationwide distribution in the states of AR, AZ, CA,FL,GA, IL, MA, MI, NC, NH, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, and WV. The country of Netherlands.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = BTA