Recall Z-0973-2018
Laerdal Medical Corporation · initiated August 31, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Affected SNs between: 170401A0001 and 170401A0270
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.
FDA-determined 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.
Details
- Recall number
- Z-0973-2018
- Initiated
- August 31, 2017
- Terminated
- June 13, 2018
- Product code
- JCX – Apparatus, Suction, Ward Use, Portable, Ac-Powered
- Quantity
- 204
- Distribution
- Nationally
- Recalling firm
- Laerdal Medical Corporation, Wappingers Falls, NY