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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm May 20, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on March 14, 2006
Recall Number Z-1032-04
Recall Event ID 29228
510(K)Number k811141  k833982  k920121  
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
Product Infant Ventilators with Electronic Manometer.

Models IV-100B; IV-200 and IV-200 SAVI.
Code Information Restricted to those ventilators with production serial numbers beginning with a ''00'' prefix.
Recalling Firm/
Manufacturer		 Sechrist Industries Inc
4225 E La Palma Ave
Anaheim CA 92807-1815
For Additional Information Contact Craig Townsend
714-579-8400
Manufacturer Reason
for Recall		 Electronic manometer malfunctions. Manometer may be illegible. The alarm for power failure may function only briefly, or not at all.
FDA Determined
Cause 2		 Other
Action Recall notification contains a test method to be used to identify defective units. Return notification that ventilator is defective will result in replacement of the electronic manometer.
Quantity in Commerce 240
Distribution Nationwide and to Malaysia, Japan, Kuwait, Sri Lanka, South Africa, Guatemala, Mexico, Morocco, Indonesia, Korea, Ecuador, Colombia, Portugal, Oman, Switzerland, Spain, Zimbabwe, Belgium, Brazil, Thailand, Argentina, Costa Rica, Taiwan, ROC, India, Russia, Saudi Arabia, Pakistan, Caribbean, Venezuela.
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 = SECHRIST
510(K)s with Product Code = CBK and Original Applicant = SECHRIST INDUSTRIES, INC.
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