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

LMA MADett, Endotracheal tube Mucosal Atomization Device, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight — recall Z-0385-2017

U.S. FDA — Device Enforcement · United States · 2016-10-27 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0385-2017
Date of alert: 2016-10-27
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Teleflex Medical
Product category: device
Product type: Devices

Reported risk: Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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