Z-1858-2023 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 5, 2023
- Initiation Date
- May 25, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12400 units
Product Description
Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506545
Reason for Recall
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Distribution Pattern
US Nationwide distribution including Puerto Rico.
Code Information
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