Z-1442-2023 Class I Terminated
FDA device recall Z-1442-2023 was initiated by Draeger Medical, Inc. on April 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 September 3, 2024). Affected quantity: 50 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 24, 2023
- Initiation Date
- April 17, 2023
- Termination Date
- September 3, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50 units
Product Description
VentStar Watertrap (P) 180, MP00361
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: 04048675422013; All lots.