FDA Device Recall Z-0077-2023
TELEFLEX LLC · Morrisville, NC
Class I — life-threatening Ongoing
Device
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
Recall record
- Recall number
Z-0077-2023- Classification
- Class I
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- US nationwide distribution
- Recall initiated
- 2022-08-29
- Classified by FDA Center
- 2022-10-14
- FDA published
- 2022-10-26
- Recalling firm
- TELEFLEX LLC
- Firm location
- Morrisville, NC
Operational response
A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.
For the official FDA enforcement record, see FDA's Recall Search.