Home / Recalls / TELEFLEX LLC / Z-0077-2023

Z-0077-2023 Class I Ongoing

Recalled by TELEFLEX LLC — Morrisville, NC

FDA device recall Z-0077-2023 was initiated by TELEFLEX LLC on August 29, 2022 and is designated Class I. Reason for recall: Incidents of device splitting or detaching during use The recall status is ongoing. Affected quantity: 12 units.

Recall Details

Product Type
Devices
Report Date
October 26, 2022
Initiation Date
August 29, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12 units

Product Description

Filter + Catheter Mount, REF 191667-000100, OUS only. Catheter mount for circuit-patient connection (Endotracheal tube and mask)

Reason for Recall

Incidents of device splitting or detaching during use

Distribution Pattern

US nationwide distribution

Code Information

UDI: (01)04026704561544(17)250728(10)KMH20H0092, (01)04026704561544(17)250728(10)KMH20H0109, (01)04026704561544(17)251028(10)KMH20L0312, (01)04026704561544(17)251028(10)KMH20L0344, (01)04026704561544(17)251128(10)KMH20M0237, (01)04026704561544(17)251228(10)KMH21A0033, (01)04026704561544(17)260128(10)KMH21B0197, (01)04026704561544(17)260328(10)KMH21D0181, (01)04026704561544(17)260828(10)KMH21J0103, (01)04026704561544(17)260828(10)KMH21J0150, (01)04026704561544(17)261228(10)KMH22A0181, (01)04026704561544(17)261228(10)KMH22A0185.

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