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.
FDA Recall Z-1502-2021 · Posted None
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Recalling FirmMedela AG Medical Technology
Recall StatusTerminated
Product CodeBTA
Date Initiated2020-12-02
Date Terminated2024-06-17
Product Quantity6,244 units
Reason for Recall
Incorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date should be "2021-07-24".
Firm 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 - [email protected]
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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