Stryker Medela REF 077.0193 AXS Universal Aspiration Tubing… recallZ-1502-2021 · Medela AG Medical Technology · initiated Dec 2, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medela AG Medical Technology or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Incorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date should be "2021-07-24".
FDA root cause category: Process control
What the company is doing
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 - [email protected]
Recall details
- Recall number
- Z-1502-2021
- Status
- Terminated
- Initiated by the company
- Dec 2, 2020
- Recalling firm
- Medela AG Medical Technology
- Quantity
- 6,244 units
- Product code
- BTA
- FDA submissions
- K170329
- 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.
Product description
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 (models, lots, serial numbers)
Catalog Number: 077.0193 UDI Code: 07612367052719 Lot Number: W-024423
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- AXS Universal Aspiration Tubing 077.0193Medela AG · Pump, Portable, Aspiration (Manual Or Powered)1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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