Stryker Medela REF 077.0193 AXS Universal Aspiration Tubing (01)07612367053921 - Product Usage: A...
FDA Recall #Z-1502-2021 — Class II — December 2, 2020
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".
Recalling Firm
Medela AG Medical Technology — Baai, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product 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.
Code Information
Catalog Number: 077.0193 UDI Code: 07612367052719 Lot Number: W-024423
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated