FDA recall Z-0868-2021

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 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

Worldwide distribution - US Nationwide distribution.

Key facts

Status

Terminated

Initiation date

2020-12-18

Report date

2021-01-27

Termination date

2023-12-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Suzhou, N/A, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0868-2021