Carina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator for treatment in hospitals by a qualified medical personnel.
FDA Recall Z-1954-2018 · Posted None
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Recalling FirmDraeger Medical, Inc.
Recall StatusTerminated
Product CodeCBK
Date Initiated2018-04-26
Date Terminated2018-09-07
Product Quantity8 units
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.
Firm 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.
Root Cause
Employee error
Distribution Pattern
Distributed to the states of CT, IL, MN, NV, SD, and WA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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