FDA Enforcement
Class II
Terminated
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.
Recall: Z-0868-2021
·
Reported January 27, 2021
Enforcement
- Recall Number
- Z-0868-2021
- Event ID
- 86702
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Laerdal Medical (Suzhou) Co., Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 27, 2021
- Initiation Date
- December 18, 2020
- Classification Date
- January 15, 2021
- Termination Date
- December 11, 2023
- Address
- Science & Technology Ind. Park, No. 19 Bldg., Huoju Road, Suzhou, N/A, N/A, China
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
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.
Code Info
Serial number range 1808090001 to 2006060045
Distribution
Worldwide distribution - US Nationwide distribution.
Quantity
5035