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.
Z-0973-2018
Product summary
- Event
- Event 79190
- Status
- Terminated
- Classification
- Class II
- Quantity
- 204
- Official record key
device-enforcement:Z-0973-2018
Official wording
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.
Code information: Affected SNs between: 170401A0001 and 170401A0270
Distribution pattern: Nationally
Derived failure modes
-
Unknown
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.