RecallRadar

FDA Device recall Z-0077-2023

Filter + Catheter Mount, REF 191667-000100, OUS only

On 2022-10-26 the FDA classified a Class I recall of Filter + Catheter Mount, REF 191667-000100, OUS only by Teleflex, citing incidents of device splitting or detaching during use.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0077-2023
ClassificationClass I
Statusongoing
Initiated2022-08-29
Published2022-10-26
Last updated2026-09-13 11:56 UTC
CompanyTeleflex
DistributionUS

Product

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

Reason

Incidents of device splitting or detaching during use

Identifiers

code_info
UDI: (01)04026704561544(17)250728(10)KMH20H0092, (01)04026704561544(17)250728(10)KMH20H0109, (01)04026704561544(17)251…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.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0077-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.