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.
This recall has been terminated (originally issued August 31, 2017).
- Company
- Laerdal Medical Corporation
- Recall Initiated
- August 31, 2017
- Terminated
- June 13, 2018
- Recall Number
- Z-0973-2018
- Quantity
- 204
- Firm Location
- Wappingers Falls, NY
- Official Source
- View on FDA website ↗
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
Nationally
Lot / Code Info
Affected SNs between: 170401A0001 and 170401A0270
Root Cause
No Marketing Application
Action Taken
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: customerservice@laerdal.com , referencing the following number: 2017-R-05.
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