Z-1502-2021 Class II Terminated
FDA device recall Z-1502-2021 was initiated by Medela AG Medical Technology on December 2, 2020 and is designated Class II. Reason for recall: Incorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date should be "2021-07-24". The recall status is terminated (terminated June 17, 2024). Affected quantity: 6,244 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 5, 2021
- Initiation Date
- December 2, 2020
- Termination Date
- June 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,244 units
Product Description
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.
Reason for Recall
Incorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date should be "2021-07-24".
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.
Code Information
Catalog Number: 077.0193 UDI Code: 07612367052719 Lot Number: W-024423