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Recall Observatory FDA recall evidence

Device product

RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480030

Z-1896-2023

May 25, 2023

Class I

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

    reason.no_named_rule · v1.0.0

    Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.