FDA Device Recall Z-1851-2023

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 504580

Lot / serial / GTIN: UDI/DI 4026704547630, Batch Numbers: 18FG03, 18FG05, 18FG13, 18GG14, 18HG22, 18HG38, 18IG09, 18JG06, 18JG14, 18JG26, 18KG09, 18KG15, 18KG23, 18LG05, 18LG12, 18LG18, 19AG05, 19AG31, 19BG01, 19BG07, 19CT32, 19CT41, 19CT55, 19DT38, 19DT45, 19DT52, 19ET05, 19ET32, 19ET60, 19ET72, 19ET77, 19FT24, 19GT10, 19GT20, 19GT38, 19GT59, 19HT05, 19IT06, 19JT42, 19JT49, 19KT17, 19LT04, 19LT17, 20AT09, 20AT14, 20AT25, 20AT32, 20AT37, 20AT46, 20AT53, 20BT05, 20BT23, 20BT47, 20CT05, 20CT12, 20CT27, 20CT36, 20CT44, 20DT14, 20DT37, 20ET16, 20ET21, 20GT06, 20GT25, KME20H0590, KME20H0973, KME20H0974, KME20H1289, KME20H1290, KME20H2924, KME20H2926, KME20K0449, KME20K0450, KME20K1414, KME20K2622, KME20L1277, KME20L1479, KME20L2302, KME20L2828, KME20M1752, KME20M1753, KME21A0381, KME21A0820, KME21A0823, KME21D1784, KME21E1286, KME21F1330, KME21J0409, KME21K2402, KME21L0372, KME21L1534, KME21L1899, KME21L2812, KME21M2036, KME21M2053, KME21M2870, KME22A0395, KME22A1237, KME22A3025, KME22A3271, KME22A3272, KME22A3283, KME22A3284, KME22A3285, KME22B1406, KME22B1996, KME22B2164, KME22B2329, KME22B2330, KME22B2496, KME22B2504, KME22B2595, KME22C0247, KME22C0865, KME22C1074, KME22C1321, KME22C1322, KME22H3393, KME22J1538, KME22J1713, KME22J3328, KME22K0537, KME22K0602, KME22K0744, KME22K0760, KME22L1503, KME22L1515, KME22M2049

Quantity: 244120 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-1851-2023
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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