RecallDepth

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.

Company
Laerdal Medical Corporation
Recall Initiated
August 31, 2017
Terminated
June 13, 2018
Recall Number
Z-0973-2018
Quantity
204
Firm Location
Wappingers Falls, NY

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

Lot / Code Info

Affected SNs between: 170401A0001 and 170401A0270

Root Cause

No Marketing Application

Action Taken

On September 5, 2017, a letter was mailed to customers notifying them that they received one of the units subject to recall. The letter requested that the customer return the affected item for a replacement. Questions or concerns can be directed to 1-877-523-7325 or email: customerservice@laerdal.com , referencing the following number: 2017-R-05.

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