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U.S. Department of Health and Human Services

Class 2 Device Recall Carina Ventilator

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  Class 2 Device Recall Carina Ventilator see related information
Date Initiated by Firm April 26, 2018
Create Date May 29, 2018
Recall Status1 Terminated 3 on September 07, 2018
Recall Number Z-1954-2018
Recall Event ID 80027
510(K)Number K072885  
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product Carina Ventilator, ventilator. Catalog no. 5704110.

Long-term ventilator for treatment in hospitals by a qualified medical personnel.
Code Information Serial nos. ASKM-0065 ASKM-0066 ASKM-0106 ASKM-0134 ASKM-0137 ASKM-0150 ASKM-0151 ASKN-0009
Recalling Firm/
Manufacturer		 Draeger Medical, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information Contact DraegerService Technical Support
1-800-437-2437
Manufacturer 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.
FDA Determined
Cause 2		 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 Dr¿ger 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = DRAEGER MEDICAL AG & CO. KG
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