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U.S. Department of Health and Human Services

Class 2 Device Recall Carina Home Ventilator

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  Class 2 Device Recall Carina Home Ventilator see related information
Date Initiated by Firm January 21, 2009
Date Posted May 14, 2009
Recall Status1 Terminated 3 on January 05, 2010
Recall Number Z-1263-2009
Recall Event ID 51447
510(K)Number K060705  
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product Carina Home Ventilator.

The device is used as a continuous respirator/ventilator for home use.
Code Information Catalog Numbers 5704757 and 5704758.
Recalling Firm/
Manufacturer		 Draeger Medical, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information Contact Technical Support
800-543-5047
Manufacturer Reason
for Recall		 The device may not generate a pilot line disconnect alarm if the pilot line becomes disconnected, which may potentially result in a substantial reduction in tidal volume delivery.
FDA Determined
Cause 2		 Software design
Action An "Urgent - Medical Device Recall" Letter dated January 2009 was issued to consignees via certified mail. The letter described the issue, specific conditions, background information, and precautions for customers. An additional letter dated January 22, 2009 was included with the "Urgent - Medical Device Recall" letter which instructed consignees to inform an enduser of the contents of the notification letter because some of the consignees are home care device/service providers. When the new hardware/software solution is available, affected devices will be updated free of charge. Direct questions about the notification letter to Drager Medical, Inc. by calling 1-800-543-5047 (press "1" at the prompt and then press "2349#"). Direct questions regarding updating your device when the new software is available, contact Drager Service Technical Support at 1-800-543-5047 (press "4" at the prompt).
Quantity in Commerce 40 units
Distribution Nationwide Distribution -- states of CA, FL, GA, HI, IL, LA, MA, MN, OH, and TX.
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 B.V.
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