Z-0868-2021 Class II Terminated
FDA device recall Z-0868-2021 was initiated by Laerdal Medical (Suzhou) Co., Ltd. on December 18, 2020 and is designated Class II. 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 suffoc… The recall status is terminated (terminated December 11, 2023). Affected quantity: 5035.
Recall Details
- Product Type
- Devices
- Report Date
- January 27, 2021
- Initiation Date
- December 18, 2020
- Termination Date
- December 11, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5035
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.
Distribution Pattern
Worldwide distribution - US Nationwide distribution.
Code Information
Serial number range 1808090001 to 2006060045