FDA Medical Device Recalls (openFDA)
Draeger Medical, Inc.: VentStar Anesthesia (N) 180, MP00333
- Recall number
- Z-1447-2023
- Recalling firm
- Draeger Medical, Inc.
- Product
- VentStar Anesthesia (N) 180, MP00333
- Status
- Terminated
- Initiated
- 2023-04-17
- Posted
- 2023-05-17
- Terminated
- 2024-09-03
- Reason
- Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
- Root cause
- Process control
- Action
- The firm distributed recall notifications to consignees via FedEx starting on 4/17/2023. Consignees are instructed to immediately stop use of affected devices, inspect current stock, and quarantine any affected devices to prevent use. Alternative therapy for patients should be instituted as soon as possible and ensure all users of affected devices within consignee organizations are aware of the recall, with copies being forwarded if devices were further distributed. To replace or return unused products, consignees are to call Draeger Customer Success between 8:00 AM - 6:00 PM EST, Monday thru Friday, at 1-800-437-2437 (option 2, then option 1), or via email at US-Medical@draeger.com. A Return Materials Authorization and pre-paid shipping label will be provided upon request. Any additional questions regarding the recall communication may be directed to Mr. Michael Kelhart between the hours of 8:00 AM - 4:30 PM by phone at 267-664-1131 or by email at mike.kelhart@draeger.com.
- Quantity
- not on file
- Distribution
- Domestic: US Nationwide Distribution.
- Lot, serial or model codes
- UDI-DI: 04048675422198; All lots.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CAI
- Firm FEI
- 2517967
- Firm city
- Telford
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28