Z-1960-2023 Class I Ongoing
FDA device recall Z-1960-2023 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: 6710 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
- 6710 units
Product Description
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080065
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: 18GT07, 18HG20, 18IG16, 18IG22, 18JG13, 19AT23, 19CT64, 19ET12, 19ET31, 19HT69, 19LT47, 20AT41, 20BT13, 20DT40, 20GT05, KME22A2193, KME22A2546, KME22B2739, KME22C2271, KME22E0189