FDA Device Recall Z-1949-2023

TELEFLEX LLC · Morrisville, NC

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780085

Lot / serial / GTIN: UDI/DI 14026704341136, Batch Numbers: 18GG25, 18LG18, 19AG19, 19DT36, 20CT32, 20GT34, KME21B2675, KME21F0887, KME22H1797

Quantity: 670 units

Reason for recall

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

Recall record

Recall number: Z-1949-2023
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US Nationwide distribution including Puerto Rico.
Recall initiated: 2023-05-25
Classified by FDA Center: 2023-06-29
FDA published: 2023-07-05
Recalling firm: TELEFLEX LLC
Firm location: Morrisville, NC

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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