FDA Medical Device Recalls (openFDA)
Medela AG Medical Technology: 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.
- Recall number
- Z-1502-2021
- Recalling firm
- Medela AG Medical Technology
- 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.
- Status
- Terminated
- Initiated
- 2020-12-02
- Posted
- not on file
- Terminated
- 2024-06-17
- Reason
- Incorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date should be "2021-07-24".
- Root 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
- 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.
- Lot, serial or model codes
- Catalog Number: 077.0193 UDI Code: 07612367052719 Lot Number: W-024423
- 510(k) numbers
- K170329
- PMA numbers
- not on file
- Product code
- BTA
- Firm FEI
- 3002807523
- Firm city
- Baai
- Firm state
- not on file
- Firm country
- Switzerland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28