Home / Recalls / TELEFLEX LLC / Z-1946-2023

Z-1946-2023 Class I Ongoing

Recalled by TELEFLEX LLC — Morrisville, NC

FDA device recall Z-1946-2023 was initiated by TELEFLEX LLC on May 25, 2023 and is designated Class I. Reason for recall: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. The recall status is ongoing. Affected quantity: 14780 units.

Recall Details

Product Type
Devices
Report Date
July 5, 2023
Initiation Date
May 25, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
14780 units

Product Description

Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780065

Reason for Recall

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

Distribution Pattern

US Nationwide distribution including Puerto Rico.

Code Information

UDI/DI 14026704341099, Batch Numbers: 18FG12, 18FG23, 18FG24, 18GT26, 18HG24, 18IG11, 18IG14, 18IG24, 18JG07, 18JG36, 18KG10, 18LG11, 18LG31, 19AG11, 19AG36, 19CT36, 19DT10, 19ET12, 19FT18, 19FT49, 19HT03, 19HT66, 19IT43, 19JT20, 19KT21, 19LT08, 19LT31, 20AT49, 20BT53, 20DT14, 20DT24, 20FT59, KME20H0325, KME20J1141, KME20L0727, KME20M0906, KME20M2652, KME21B0072, KME21C0332, KME21C0923, KME21C3299, KME21D0466, KME21D1903, KME21L1006, KME21L1007, KME21M1776, KME21M3025, KME21M3026, KME22A0377, KME22B1011, KME22C1836, KME22C2817, KME22D1076, KME22D2087, KME22F1763, KME22G1315, KME22G3080, KME22H0004, KME22H2233, KME22J1231, KME22J2727, KME22K0999, KME22K1158, KME22K1240, KME22M3068

Other recalls by TELEFLEX LLC

  • Z-1889-2023 Class I — Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112 (May 25, 2023)
  • Z-1860-2023 Class I — Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 1700100 (May 25, 2023)
  • Z-1900-2023 Class I — Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150020 (May 25, 2023)
  • Z-1899-2023 Class I — RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480045 (May 25, 2023)
  • Z-1871-2023 Class I — Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181040 (May 25, 2023)
  • Z-1827-2023 Class I — Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170050 (May 25, 2023)
  • Z-1874-2023 Class I — Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382030 (May 25, 2023)
  • Z-1964-2023 Class I — Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 1120800 (May 25, 2023)
  • Z-1950-2023 Class I — Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, (May 25, 2023)
  • Z-1841-2023 Class I — Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170140 (May 25, 2023)

FDA data resources