FDA Device Recall Z-1858-2023

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

Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506545

Lot / serial / GTIN: UDI/DI 4026704547708, Batch Numbers: 18FG05, 18FG13, 18GG20, 18HG16, 18IG06, 18IG12, 18JG04, 18JG14, 18JG21, 18JG34, 18KG35, 18LG02, 18LG18, 18LG28, 19BG21, 19CT49, 19FT35, 19GT20, 19GT28, 19GT38, 19GT59, 19GT65, 19HT24, 19HT80, 19IT29, 19KT25, 19KT48, 19LT38, 20AT09, 20BG16, 20BT05, 20CT05, 20CT36, 20CT44, 20DT37, 20GG45, KME20H2927, KME20H2928, KME20K2248, KME20L0620, KME20L1471, KME20L1472, KME20L2030, KME20M2482, KME21A1892, KME21A1893, KME21A2811, KME21B0576, KME22G3102, KME22J2956, KME22K2778, KME22L3057, KME23A2083, KME23B1203

Quantity: 12400 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-1858-2023
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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