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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 June 08, 2005
Date Posted August 16, 2005
Recall Status1 Terminated 3 on April 06, 2012
Recall Number Z-1371-05
Recall Event ID 32468
510(K)Number K010401  
Product Classification Accessory To Continuous Ventilator (Respirator) - Product Code MOD
Product Tri-Plex Adapter, single unit (MD-04000 )or box of 25 (MD-04001) or case of 100 (MD-04002). Sterile. Single Use.
Code Information Lot 2005001
Recalling Firm/
Manufacturer		 Medical Device Group Inc.
12675 Stowe Dr Ste B
Poway CA 92064-8848
For Additional Information Contact Delton West
888-575-6341
Manufacturer Reason
for Recall		 Device separation presenting a choking hazard.
FDA Determined
Cause 2		 Other
Action Distributors were contacted by telephone on June 8, 2005, distributors were requested to return product. Letters were also sent by mail with proof of reciept on June 10, 2005. Firm reports that all customers have been notified.
Quantity in Commerce 2,282
Distribution Nationwide, Brasil and Canada
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 = MOD and Original Applicant = THE MEDICAL DEVICE GROUP, INC.
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