The Recall Desk
SevereFDA (Devices)·Z-0077-2023·Announced 2022-10-26

Teleflex Catheter Mount and Filter May Split or Detach During Use

Catheter mounts with filters (REF 191667-000100) used to connect endotracheal tubes or masks to breathing circuits may split or detach during patient use. Teleflex is recalling affected units distributed nationwide.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I classification requires a minimum severity score of 4. Device splitting or detaching during respiratory therapy poses serious risk of unintended circuit disconnection and loss of airway support in critical care settings, though no patient injuries or deaths are reported in the source material.

Plain-English summary

The Filter + Catheter Mount (REF 191667-000100), manufactured by Teleflex LLC, is designed to connect endotracheal tubes or masks to patient breathing circuits. The product may split or detach from the circuit during use.

The FDA has classified this as a Class I recall, indicating serious potential risk. Device splitting or detachment could result in loss of connection between the patient and the breathing circuit, potentially compromising respiratory support.

Affected units are identified by specific UDI codes with batch codes ranging from July 2025 through December 2026. Distribution was nationwide in the United States. The recalled product was supplied in 12-unit quantities.

Healthcare facilities should immediately identify and quarantine affected units using the batch codes provided in the official FDA notice. Healthcare providers caring for patients who have used affected devices should consult with their facility's medical staff for guidance on patient assessment and monitoring.

The recalled product

Product
Filter + Catheter Mount, REF 191667-000100, OUS only. Catheter mount for circuit-patient connection (Endotracheal tube and mask)
Manufacturer
TELEFLEX LLC
Category
Medical Device — Respiratory / Airway Management
Hazard
  • device-splitting
  • device-detachment
  • circuit-disconnection

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

  • 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

Distributed nationwide across the United States.

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