Z-1455-2023 Class I Terminated

Recalled by Draeger Medical, Inc. — Telford, PA

FDA device recall Z-1455-2023 was initiated by Draeger Medical, Inc. on Apr 17, 2023 and is designated Class I. Reason for recall: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. The recall status is terminated (terminated Sep 3, 2024). Affected quantity: 18,160 units.

Recall Details

Product Type
Devices
Report Date
May 24, 2023
Initiation Date
Apr 17, 2023
Termination Date
Sep 3, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
18,160 units

Product Description

Ventstar Coax 180, MP03374

Reason for Recall

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

Distribution Pattern

Domestic: US Nationwide Distribution.

Code Information

UDI-DI: 04048675545576; All lots.

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-1455-2023
openFDA file date
Oct 6, 2026
Loaded by RegDataLab
Oct 12, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it. FDA may have changed the recall since.