FDA Enforcement
Class II
Terminated
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.
Recall: Z-0973-2018
·
Reported March 21, 2018
Enforcement
- Recall Number
- Z-0973-2018
- Event ID
- 79190
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Laerdal Medical Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 21, 2018
- Initiation Date
- August 31, 2017
- Classification Date
- March 12, 2018
- Termination Date
- June 13, 2018
- Address
- PO Box 1840, 167 Myers Corners Rd, Wappingers Falls, NY, 12590-3869, United States
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
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 Info
Affected SNs between: 170401A0001 and 170401A0270
Distribution
Nationally
Quantity
204