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 Aug 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: Oct 26, 2022
Initiation Date: Aug 29, 2022
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.

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0077-2023
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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