Device product
RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480030
Z-1896-2023
Product summary
- Firm
- TELEFLEX LLC
- Event
- Event 92373
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 21284 units
- Official record key
device-enforcement:Z-1896-2023
Official wording
Reason: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Code information: UDI/DI 14026704341501, Batch Numbers: 18GG16, 18HG10, 18HG25, 18IG03, 19BG12, 19BG16, 19CT42, 19CT64, 19DT36, 19ET09, 19ET31, 19ET53, 19GT02, 19IT38, 19JT21, 19JT55, 19KT20, 19KT37, 19LT31, 20AT40, 20DT01, 20DT20, 20ET30, 20GT38, KME20J3096, KME20K2145, KME20L1345, KME20M1802, KME21B0621, KME21B2379, KME21C0168, KME22A1495, KME22A2394, KME22A2396, KME22B2938, KME22C2668, KME22C2669, KME22C2687, KME22D3223, KME22E1149, KME22E2287, KME22G1233, KME22G1879, KME23B0133, KME23B0560, KME23B0717, KME23B2197
Distribution pattern: US Nationwide distribution including Puerto Rico.
Derived failure modes
-
Unknown
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.