Z-0868-2021 Class II Terminated

Recalled by Laerdal Medical (Suzhou) Co., Ltd. — Suzhou, N/A

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