Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0973-2018 — 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

U.S. FDA — Device Enforcement · United States · 2017-08-31 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0973-2018
Date of alert: 2017-08-31
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Laerdal Medical Corporation
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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