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

Recall Z-1085-2015 — LMA (Laryngeal Mask Airway) Supreme (New Cuff) Size 5, Sterile, Single use, Product Usage: Achieve and maintain control of airway during routine anaesthesia in fasted patient using either spontaneous or positive pressure ventilation, cardiopulmonary resuscitation, the failed intubation situat

U.S. FDA — Device Enforcement · United States · 2015-01-13 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1085-2015
Date of alert: 2015-01-13
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Teleflex Medical
Product category: device
Product type: Devices

Reported risk: The labelling of units from the affected lot indicates that it contains a size 5 LMA Supreme (New Cuff), but may contain a size 4 LMA Supreme (New Cuff).

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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