Device product

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

Z-0077-2023

August 29, 2022

Class I

Product summary

Firm: TELEFLEX LLC
Event: Event 90816
Status: Ongoing
Classification: Class I
Quantity: 12 units
Official record key: device-enforcement:Z-0077-2023

Official wording

Reason: Incidents of device splitting or detaching during use

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.

Distribution pattern: US nationwide distribution

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Incidents of device splitting or detaching during use