FDA recall Z-0973-2018

Laerdal Medical Corporation · Class II · device

Product

LCSU 4, Laerdal Compact Suction Unit The LCSU 4 is a portable, electrically powered, medical suction device intended for field and transport use. It is intended for intermittent operation to remove secretions, blood or vomit from a patient s airway to allow ventilation. Higher vacuum levels are generally selected for oropharyngeal suction, and lower vacuum levels are usually selected for tracheal suctioning and the suctioning of children and infants.

Reason for recall

A shipment of LCSU 4 suction units and canisters attempted importation into the United States but was refused by FDA for lack of necessary approvals with CDRH by the foreign firms.

Distribution

Nationally

Key facts

Status
Terminated
Initiation date
2017-08-31
Report date
2018-03-21
Termination date
2018-06-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Wappingers Falls, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0973-2018