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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmMay 20, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on March 14, 2006
Recall NumberZ-1032-04
Recall Event ID 29228
510(K)NumberK811141 K833982 K920121 
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
ProductInfant 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 ContactCraig 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
ActionRecall 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 Commerce240
DistributionNationwide 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 CycleTPLC 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) Database510(K)s with Product Code = CBK
510(K)s with Product Code = CBK
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