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Recall Observatory FDA recall evidence

Device 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.

Z-1502-2021

December 02, 2020

Class II

Product summary

Firm
Medela AG Medical Technology
Event
Event 87551
Status
Terminated
Classification
Class II
Quantity
6,244 units
Official record key
device-enforcement:Z-1502-2021

Official wording

Reason: Incorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date should be "2021-07-24".

Code information: Catalog Number: 077.0193 UDI Code: 07612367052719 Lot Number: W-024423

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Incorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date should be "2021-07-24".