Recall Z-1450-2023— Draeger Medical, Inc.
Class I · Terminated
Class I FDA medical device recall by Draeger Medical, Inc., initiated 2023-04-17, terminated 2024-09-03. FDA's recall record names no specific 510(k) clearance for this event. Product: VentStar Bag Set (N) 110, MP00383. Reason: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces..
- Recalling firm
- Draeger Medical, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2023-04-17
- Terminated
- 2024-09-03
- Firm location
- Telford, PA, United States
Product description
VentStar Bag Set (N) 110, MP00383
Reason for recall
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Data sourced from openFDA. This site is unofficial and independent of the FDA.