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Recall Observatory FDA recall evidence

Device product

Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780080

Z-1948-2023

May 25, 2023

Class I

Product summary

Firm
TELEFLEX LLC
Event
Event 92373
Status
Ongoing
Classification
Class I
Quantity
9070 units
Official record key
device-enforcement:Z-1948-2023

Official wording

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

Code information: UDI/DI 14026704341129, Batch Numbers: 18FG33, 18GG23, 18GG34, 18HG30, 18IG11, 18IG18, 18JG21, 18JG35, 18KG19, 18KG41, 19AG15, 19BG04, 19BG19, 19GT65, 19HT68, 19IT15, 19LT21, 20AT26, 20CT12, 20CT13, 20CT32, 20DT35, 20FT19, KME20M3089, KME20M3090, KME21A1299, KME21A2090, KME21B0716, KME21B1783, KME21B1962, KME21B2204, KME21B2676, KME21C0599, KME22B0591, KME22C2317, KME22D0156, KME22D2122, KME22D2752, KME22E1153, KME22G0816, KME22H2094, KME22H2235, KME22H3271, KME22J0148, KME22J0532, KME22J3210, KME22K2844

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.