Z-1854-2023 Class I Ongoing
FDA device recall Z-1854-2023 was initiated by TELEFLEX LLC on May 25, 2023 and is designated Class I. Reason for recall: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. The recall status is ongoing. Affected quantity: 17551 units.
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
- 17551 units
Product Description
Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506525
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 4026704547661, Batch Numbers: 18FG05, 18FG13, 18GG17, 18GG28, 18HG16, 18HG25, 18HG29, 18HG35, 18HG38, 18IG06, 18IG12, 18IG24, 18IG27, 18JG11, 18JG14, 18JG26, 18JG34, 18KG23, 18LG05, 18LG12, 18LG22, 19AG18, 19AG21, 19AG37, 19CT32, 19CT55, 19ET45, 19GT05, 19GT20, 19GT38, 19GT59, 19HT05, 19HT15, 19HT40, 19HT80, 19IT29, 19KT08, 19KT25, 19KT41, 19KT48, 19LT04, 20AT25, 20AT46, 20BT13, 20BT27, 20CT12, 20CT22, 20CT36, 20CT51, 20DT37, 20ET16, 20ET28, 20FT44, KME20L0615, KME20M2047, KME21A1889, KME21A1890, KME21A2804, KME21B1143, KME21B1672, KME21C0063, KME21C0301, KME21M1833, KME22B0302, KME22B1071, KME22C3357, KME22D0784, KME22D1062, KME22D3648, KME22E1130, KME22F0161, KME22F1501, KME22G0561, KME22G1100, KME22H2626, KME22K0013, KME22K0331, KME22K2365, KME22L0760