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
- Recall Number
- Z-0973-2018
- Event Number
- 79190
- Firm
- Laerdal Medical Corporation
- FEI Number
- 2425852
- Product Code
- JCX
- Status
- Terminated
- Root Cause
- No Marketing Application
- Initiated
- August 31, 2017
- Terminated
- June 13, 2018
- Address
- 167 Myers Corners Rd PO Box 1840, Wappingers Falls, NY, 12590-3869
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.
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.
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.
Nationally
204