Baai, N/A, Switzerland
Medela AG Medical Technology recalls
1 recall recorded since 2018, most recently on 2 December 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 2 December 2020
- Terminated
- 17 June 2024
- Reason
- Incorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date should be "2021-07-24".
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1502-2021
- 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.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.