FDA Device recall Z-0077-2023
Filter + Catheter Mount, REF 191667-000100, OUS only
- FDA Device
- Class I
- ongoing
- Published 2022-10-26
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
| Agency | FDA Device |
|---|---|
| Recall number | Z-0077-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2022-08-29 |
| Published | 2022-10-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Teleflex |
| Distribution | US |
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
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