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Recall Observatory FDA recall evidence

Device product

RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480045

Z-1899-2023

May 25, 2023

Class I

Product summary

Firm
TELEFLEX LLC
Event
Event 92373
Status
Ongoing
Classification
Class I
Quantity
30391 units
Official record key
device-enforcement:Z-1899-2023

Official wording

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

Code information: UDI/DI 14026704341532, Batch Numbers: 18FG02, 18FG14, 18GT16, 18HG37, 18IG13, 18KG34, 18LG03, 19AG04, 19AG08, 19AG23, 19AG38, 19BG35, 19CG05, 19DT09, 19FT12, 19IT38, 19JT19, 19JT21, 19KT58, 19LT09, 19LT27, 20AT06, 20BG15, 20CT07, 20CT12, 20CT54, 20DT01, 20DT09, 20ET30, 20FT58, 20GT22, KME20H0774, KME20J0792, KME20J2687, KME20M0861, KME20M1576, KME20M1925, KME20M1926, KME20M3207, KME21A0769, KME21B0450, KME21C0314, KME21C1807, KME21K1189, KME21K1920, KME21M1895, KME21M2015, KME21M2776, KME21M3038, KME22B2939, KME22C0808, KME22C0928, KME22D0939, KME22D0940, KME22D1836, KME22D2309, KME22F0391, KME22F1537, KME22F2459, KME22F2526, KME22G1183, KME22H0051, KME22H3521, KME22J2886, KME22K1019, KME22M2104, KME23A1068, KME23A1487, KME23A2313

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.