FDAClass IJuly 5, 2023

RUSCHELIT Safety Clear Tracheal Tube recall

RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480040

Why was RUSCHELIT Safety Clear Tracheal Tube recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI/DI 14026704341525, Batch Numbers: 18FG14, 18FG22, 18JG08, 18KG25, 18LG04, 18LG30, 19DT35, 19DT36, 19ET09, 19ET31, 19ET51, 19HT60, 19IT32, 19IT43, 20AT06, 20AT39, 20BT01, 20BT53, 20CT12, 20CT27, 20CT54, 20DT04, 20ET30, 20FT58, KME20G0182, KME20H0372, KME20H0373, KME20J0924, KME20J2043, KME21C2368, KME21K1187, KME21K1188, KME21K1977, KME21M1084, KME21M1842, KME21M1845, KME21M2733, KME21M2734, KME21M2735, KME21M2736, KME22B2019, KME22C1693, KME22D0057, KME22D0180, KME22D0819, KME22D1066, KME22D3269, KME22E0602, KME22E2648, KME22E2681, KME22F1440, KME22F1692, KME22F2455, KME22G2312, KME22H1126, KME22H1212, KME22H2302, KME22J1615, KME22K0283, KME22K0632, KME22K1096, KME22M1155, KME22M1478, KME22M1659, KME23B3174

Product
RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480040
Recalling firm
TELEFLEX LLC
Quantity
37076 units
Distribution
US Nationwide distribution including Puerto Rico.
Recall date
July 5, 2023
Classification
Class I
Status
Ongoing
Agency
FDA (device)
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