Recall Z-0973-2018— Laerdal Medical Corporation

Name: FDA recall Z-0973-2018
Creator: U.S. Food and Drug Administration
Published: 2017-08-31

Class II · Terminated

Class II FDA medical device recall by Laerdal Medical Corporation, initiated 2017-08-31, terminated 2018-06-13. It names one FDA 510(k) clearance: K120065. 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: 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..

Recalling firm: Laerdal Medical Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-08-31
Terminated: 2018-06-13
Firm location: Wappingers Falls, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K120065 — PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIESPlaxtron Industrial (M) Sdn. Bhd.·cleared 2012-04-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.