Laerdal Compact Suction Unit (LCSU 4), Catalog Numbers 880051, 880061, 881151, 880052, 880062, ...
FDA Recall #Z-0868-2021 — Class II — December 18, 2020
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.
Recalling Firm
Laerdal Medical (Suzhou) Co., Ltd. — Suzhou, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
5035
Distribution
Worldwide distribution - US Nationwide distribution.
Code Information
Serial number range 1808090001 to 2006060045
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated