Z-1502-2021Class II

Stryker Medela REF 077.0193 AXS Universal Aspiration Tubing (01)07612367053921 -

Name: Z-1502-2021 Stryker Medela REF 077.0193 AXS Universal Aspiration Tubing (01)07612367053921 -
Creator: Medela AG Medical Technology
Published: 2020-12-02
License: https://open.fda.gov/license/

Medela AG / initiated 2020-12-02 / Terminated / root cause: manufacturing process

FDA source

Medela AG Medical Technology began a recall of Stryker Medela REF 077.0193 AXS Universal Aspiration Tubing (01)07612367053921 - Product Usage: AXS Universal Aspiration Tubing is used with the Dominant Flex... on 2020-12-02. FDA classified it as Class II and gives the reason as "Incorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date should be "2021-07-24"". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1502-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-02
Posted: 2021-04-27
Terminated: 2024-06-17
Recalling firm: Medela AG
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.
Product code: BTA Pump, Portable, Aspiration (Manual Or Powered)
Reason for recall: Incorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date should be "2021-07-24".
Root cause tag: manufacturing process
FDA 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 - [email protected]
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.
Product codes and lots: Catalog Number: 077.0193 UDI Code: 07612367052719 Lot Number: W-024423

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1502-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1502-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-05	2021-04-27

Product code BTA

K170329Class IIBasic, Dominant FlexModela AG / cleared 2017-03-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)