Recall Z-0868-2021— Laerdal Medical (Suzhou) Co., Ltd.
Class II · Terminated
Class II FDA medical device recall by Laerdal Medical (Suzhou) Co., Ltd., initiated 2020-12-18, terminated 2023-12-11. It names one FDA 510(k) clearance: K120065. Product: 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 airway to allow ventilation.. 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..
- Recalling firm
- Laerdal Medical (Suzhou) Co., Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-12-18
- Terminated
- 2023-12-11
- Firm location
- Suzhou, N/A, China
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 airway to allow ventilation.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.