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.
FDA Recall Z-0973-2018 · Posted None
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Recalling FirmLaerdal Medical Corporation
Recall StatusTerminated
Product CodeJCX
Date Initiated2017-08-31
Date Terminated2018-06-13
Product Quantity204
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.
Firm Action
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: [email protected] , referencing the following number: 2017-R-05.
Root Cause
No Marketing Application
Distribution Pattern
Nationally
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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