Z-2248-2023Class I

Carina Sub-Acute Care Ventilator

Name: Z-2248-2023 Carina Sub-Acute Care Ventilator
Creator: Draeger Medical, Inc.
Published: 2023-07-12
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2023-07-12 / Open, Classified / root cause: manufacturing process

FDA source

Draeger Medical, Inc. began a recall of Carina Sub-Acute Care Ventilator on 2023-07-12. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2248-2023
Classification: Class I
Status: Open, Classified
Initiated: 2023-07-12
Posted: 2023-08-18
Recalling firm: Draeger, Inc.
Product: Carina Sub-Acute Care Ventilator
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: 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 tag: manufacturing process
FDA 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 [email protected]. The Medical Device Recall Response form is to be returned by fax 215-372-2940 or email: [email protected] to Draeger upon completion.
Quantity in commerce: 11,621 units
Distribution: US Nationwide Distribution.
Product codes and lots: Part No. 5704110; UDI-DI 04048675398516; All Serial No.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2248-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2248-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-08-30	2023-08-18

Product code CBK

K072885Class IICarina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG / cleared 2008-04-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)