FDA Medical Device Recalls (openFDA)
Draeger Medical, Inc.: Carina Sub-Acute Care Ventilator
- Recall number
- Z-2248-2023
- Recalling firm
- Draeger Medical, Inc.
- Product
- Carina Sub-Acute Care Ventilator
- Status
- Open, Classified
- Initiated
- 2023-07-12
- Posted
- 2023-08-18
- Terminated
- not on file
- Reason
- Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed the acceptable uptake level during continuous use (>30 days) in pediatric patients.
- Root cause
- Nonconforming Material/Component
- Action
- The firm, Drager, sent an "Urgent Medical Device Recall" to customers by mail on 07/12/2023. The medical device recall notification instructs customers on how to utilize the Carina Ventilator until units can be corrected in the field by way of replacement of the blower to remove the presence of PE-PUR foam. Customers may continue to use the device until it has been modified provided that the set minute volume exceeds 3.6 l/min, only adult patients are ventilated, and only a Draeger ventilation hose with leak valve is used. The firm states that a new designed blower cover will be available in the early part of the fourth quarter of 2023 and Draeger will facilitate field service free of charge. Customers are to ensure all users and maintenance staff that utilize the recalled device are made aware of the recall notice. Customers with any questions regarding the operation of the Carina Ventilator are to contact Technical Support between 8:00 AM and 8:00 PM EST at 1-800-437-2437 (press 2, then 2, then 2); customers with any questions about the recall notice are to contact Michael Kelhart from 8:00 AM to 4:30 PM EST at 267-664-1131 or by email at mike.kelhart@draeger.com. The Medical Device Recall Response form is to be returned by fax 215-372-2940 or email: ditelford.quality@draeger.com to Draeger upon completion.
- Quantity
- 11,621 units
- Distribution
- US Nationwide Distribution.
- Lot, serial or model codes
- Part No. 5704110; UDI-DI 04048675398516; All Serial No.
- 510(k) numbers
- ["K072885"]
- PMA numbers
- not on file
- Product code
- CBK
- 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
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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