Laerdal LCSU 4 Suction Units Refused Importation for Lack of FDA Approval
Laerdal Medical Corporation is recalling 204 LCSU 4 suction units that were refused entry into the U.S. by the FDA because they lacked necessary CDRH approvals.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is regulatory (lack of approval) rather than a direct physical defect causing injury, and no illnesses or injuries are reported, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Laerdal Medical Corporation is recalling 204 units of the LCSU 4, Laerdal Compact Suction Unit. These are portable, electrically powered medical suction devices intended for field and transport use to remove secretions, blood, or vomit from a patient's airway. The affected serial numbers range from 170401A0001 to 170401A0270.
The recall was initiated because a shipment of these suction units and canisters attempted importation into the United States but was refused by the FDA. The refusal occurred because the foreign firms lacked the necessary approvals with the Center for Devices and Radiological Health (CDRH). The products were distributed nationally.
Consumers and healthcare facilities should stop using the affected LCSU 4 units immediately. Laerdal Medical Corporation is the recalling firm responsible for the recall.
The recalled product
- 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. High
- Manufacturer
- Laerdal Medical Corporation
- Category
- Medical Device — Suction Unit
- Affected units
- 204
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Affected SNs between: 170401A0001 and 170401A0270
Distribution
Distribution scope not specified by the agency.
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