Suzhou, N/A, China
Laerdal Medical (Suzhou) Co., Ltd. recalls
1 recall recorded since 2018, most recently on 18 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
- 18 December 2020
- Terminated
- 11 December 2023
- Reason
- Component failures may cause the unit to lose all suction. Users will need to obtain alternate suction devices or methods, leading to a delay in treatment and, in worst case scenario, potential suffocation if alternative suction or ventilation method is not administered by the user.
- Distribution
- Worldwide distribution - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0868-2021
- Laerdal Compact Suction Unit (LCSU 4), Catalog Numbers 880051, 880061, 881151, 880052, 880062, 881152 - Product Usage: It is intended for intermittent operation to remove secretions, blood or vomit from a patient s air
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.