Z-1961-2023 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
- 17950 units
Product Description
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080070
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 14026704341266, Batch Numbers: 18FG19, 18GG19, 18HG28, 18IG06, 18IG19, 18JG13, 18JG17, 18KG13, 18LT07, 19BG19, 19CT26, 19DT20, 19ET12, 19ET36, 19HT26, 19HT69, 19JT21, 19KT14, 19LT31, 19LT51, 20AT22, 20AT58, 20BT13, 20BT42, 20CT13, 20DT10, 20ET12, 20FT11, 20FT19, 20GG40, 20GT38, KME20K2577, KME20L1985, KME20M1771, KME20M1772, KME21F1585, KME21J0644, KME21J1078, KME22A1109, KME22A1781, KME22B0401, KME22F1174, KME22F2171, KME22G1295, KME22G2999