Z-1954-2018Class II

Carina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator for treatment in hospitals by a...

Name: Z-1954-2018 Carina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator for treatment in hospitals by a...
Creator: Draeger Medical, Inc.
Published: 2018-04-26
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2018-04-26 / Terminated / root cause: manufacturing process

FDA source

Draeger Medical, Inc. began a recall of Carina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator for treatment in hospitals by a qualified medical personnel on 2018-04-26. FDA classified it as Class II and gives the reason as "The valve assembly material may become corroded due to insufficient cleaning by a supplier. There is a risk of the breathing gas becoming contaminated in the affected devices". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1954-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-26
Posted: 2018-05-29
Terminated: 2018-09-07
Recalling firm: Draeger, Inc.
Product: Carina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator for treatment in hospitals by a qualified medical personnel.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: The valve assembly material may become corroded due to insufficient cleaning by a supplier. There is a risk of the breathing gas becoming contaminated in the affected devices.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On April 27, 2018, the recalling firm contacted its consignees by telephone prior to sending out Urgent Medical Device Recall notifications via e-mail. Customers were instructed to remove affected devices from operation immediately. The firm provided replacement devices so customers could send their affected ventilator to the firm's repair center for update once the required parts were available. Customers were also asked to inform all affected users at each site. If you have any questions regarding this letter please contact Michael Kelhart between the hours of 8:00 AM 4:30 PM EST at 1-800-437-2437. For questions regarding the operation and/or servicing of your Carina Ventilator please contact Drger Service Technical Support between the hours of 8:00 AM 8:00 PM EST at 1-800-437-2437.
Quantity in commerce: 8 units
Distribution: Distributed to the states of CT, IL, MN, NV, SD, and WA.
Product codes and lots: Serial nos. ASKM-0065 ASKM-0066 ASKM-0106 ASKM-0134 ASKM-0137 ASKM-0150 ASKM-0151 ASKN-0009

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1954-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1954-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-29

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)