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U.S. Department of Health and Human Services

Class 2 Device Recall Sequoia

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  Class 2 Device Recall Sequoia see related information
Date Initiated by Firm March 25, 2005
Date Posted August 03, 2005
Recall Status1 Terminated 3 on August 30, 2006
Recall Number Z-1068-05
Recall Event ID 31611
510(K)Number k000890  k003455  
Product Classification oxygen conservers - Product Code BZD
Product Sequoia Oxymatic electronic oxygen conservers. Models OM-302, OM-311 ***and OM-312***.
Code Information For model #OM-302: Serial #21404202668-21404202680, 21404202682-21404202706, 21404202708-21404202709, 21404202711, 21404202713-21404202715, 21404202722, 21404202725, 21404202728, 21404202730, 21404202733-21404202735, 21404202738-21404202739, 21404202758, 21404202761, 21404202763; For model #OM-311: Serial #21404105027, 21404105030, 2140410503041, 21404105030, 21404105054-21404105055-21404105061, 21404105063-21404105066, 21404105068-21404105070, 21404105073-21404105074, 21404105076, 21404105078-21404105083, 21404105085-21404105086, 21404105089-21404105091, 21404105093-21404105094, 21404105096, 21404105100-21404105102, 21404105105, 21404105107-21404105113, 21404105115-21404105116, 21404105119, 21404105123-21404105124, 21404105127-21404105128, 21404105130-21404105131, 21404105133, 21404105137-21404105139, 21404105142-21404105144, 21404105151-21404105152, 21404105157, 21404105161, 21404105164-21404105168, 21404105170, 21404105172, 21404105178, 21404105180, 21404105182, 21404105185, 21404105194, 21404105201, 21404105204, 21404105206, 21404105209, 21404105211-21404105213, 21404105218, 21404105270-21404105271, 21404105273-21404105274, 21404105276-21404105277, 21404105279; For model #OM-312: Serial #21404301082-21404301159, 21404301161-21404301178
Recalling Firm/
Manufacturer		 Chad Therapeutics Inc
21622 Plummer St
Chatsworth CA 91311-4106
For Additional Information Contact Shahan Moses
818-882-0883
Manufacturer Reason
for Recall		 "Shot size" below manufacturing specifications. Risk of less than the specified quantity of oxygen delivered per pulse.
FDA Determined
Cause 2		 Other
Action Firm recalled via email and letter on 3/25/2005. Firm is requesting returns of all units. Recall is on-going and is to the user or patient level.
Quantity in Commerce ***244 units***
Distribution Nationwide and to Canada, Sweden, Norway***
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 = BZD and Original Applicant = CHAD THERAPEUTICS, INC.
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