LCSU 4, Laerdal Compact Suction Unit The LCSU 4 is a portable, electrically powered, medical...
FDA Device Recall #Z-0973-2018 — Class II — August 31, 2017
Recall Summary
| Recall Number | Z-0973-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 31, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Laerdal Medical Corporation |
| Location | Wappingers Falls, NY |
| Product Type | Devices |
| Quantity | 204 |
Product 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 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 Pattern
Nationally
Lot / Code Information
Affected SNs between: 170401A0001 and 170401A0270
Other Recalls from Laerdal Medical Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1341-2026 | Class II | Laerdal Compact Suction Unit 4 RTCA version (... | Jan 13, 2026 |
| Z-1873-2017 | Class II | Laerdal Compact Suction Unit ¿ 4 under the foll... | Jan 8, 2017 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.