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