FDA Device Recall Z-1847-2023

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 Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504560

Lot / serial / GTIN: UDI/DI 4026704547593, Batch Numbers: 18FG03, 18FG15, 18FG28, 18GG24, 18IG27, 18JG02, 18JG17, 18JG26, 18JG34, 18KG09, 18KG35, 18LG05, 18LG12, 18LG18, 18LG37, 19AG27, 19AG37, 19BG12, 19CT32, 19CT41, 19CT55, 19CT58, 19ET66, 19ET77, 19FT14, 19FT24, 19FT35, 19GT05, 19GT45, 19HT05, 19HT61, 19JT42, 19KT17, 19KT21, 19KT65, 19LT04, 19LT23, 20AT09, 20AT37, 20AT53, 20BT51, 20CT05, 20CT12, 20CT36, 20DT37, 20ET04, 20FT10, 20FT35, 20GT06, KME20H0129, KME20H0906, KME20H1791, KME20H1847, KME20J0848, KME20K1550, KME20L0336, KME20M0492, KME21E1412, KME21G2207, KME21H0839, KME21H0972, KME21H1124, KME21K0660, KME21K1165, KME21L0442, KME21L0443, KME21L1900, KME21L2539, KME21M1391, KME22A1432, KME22B1411, KME22C1068, KME22C2858, KME22D0479, KME22D0482, KME22D0592, KME22D2846

Quantity: 103842 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-1847-2023
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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