FDA Device Recall Z-1852-2023

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 504585

Lot / serial / GTIN: UDI/DI 4026704547647, Batch Numbers: 18FG13, 18FG15, 18FG25, 18GG20, 18GG28, 18HG12, 18HG19, 18IG06, 18IG27, 18JG02, 18JG23, 18JG26, 18KG18, 18KG23, 19AG05, 19AG31, 19AG37, 19CT17, 19CT58, 19CT71, 19DT02, 19ET32, 19ET45, 19FT14, 19FT24, 19GT52, 19HT61, 19HT80, 19IT39, 19KT17, 19KT48, 19LT50, 20AT32, 20AT53, 20BT05, 20CT12, 20CT44, 20DT09, 20DT37, 20GG27, 20GG45, 20GT38, KME20H0532, KME20J2404, KME20J2405, KME20K2625, KME20L0624, KME20L1482, KME20L2303, KME20L2832, KME21E1295, KME21K1874, KME21M1728, KME21M2447, KME21M2519, KME22B0987, KME22B1754, KME22B2155, KME22C0679, KME22C0866, KME22C2001, KME22C2381, KME22D0823, KME22F1553, KME22F2230, KME22H0145, KME22J0252, KME22J0259, KME22J0470, KME22J2352, KME22L2186, KME22L2295, KME22L2804

Quantity: 56640 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-1852-2023
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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