Z-0973-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 21, 2018
- Initiation Date
- August 31, 2017
- Termination Date
- June 13, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 204
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.
Distribution Pattern
Nationally
Code Information
Affected SNs between: 170401A0001 and 170401A0270