Medical device recalls High risk

TELEFLEX LLC recalls Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780065

Recall date
May 25, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1946-2023
FDA classification
Class I
Brand / firm
TELEFLEX LLC
Sold / distributed
US Nationwide distribution including Puerto Rico.

Why it was recalled

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780065

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