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U.S. Department of Health and Human Services

Class 2 Device Recall Cardiovascular Procedure KitTerumo Cardiovascular Systems Corporation

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  Class 2 Device Recall Cardiovascular Procedure KitTerumo Cardiovascular Systems Corporation see related information
Date Initiated by Firm June 08, 2010
Date Posted September 29, 2010
Recall Status1 Terminated 3 on February 29, 2012
Recall Number Z-2615-2010
Recall Event ID 56413
510(K)Number K900640  
Product Classification Cardiovascular Procedure Kits - Product Code DTR
Product Cardiovascular Procedure Kit, (MP4 w/ Conducer Component Utilized), labeled in part ***RWJ Hospital***, Item # 71305-03
Code Information Lot numbers: MD15, and  MD26   
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Corporation
125 Blue Ball Road
Elkton MD 21921-5315
For Additional Information Contact Mike Silvestri
410-392-7102
Manufacturer Reason
for Recall		 Medical device vent port may be occluded and prevent delivery of priming fluid.
FDA Determined
Cause 2		 Equipment maintenance
Action Consignees were contacted on June 8, 2010, by phone, fax, email and priority mail to advise distributors and end-users of the potential occluded vent port defect and provide instructions for the replacement product recall. Consignees were mailed follow-up communications by priority overnight mail on June 9, 2010.
Quantity in Commerce 110 kits
Distribution The products were distributed nationwide.
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 = DTR and Original Applicant = 3M COMPANY
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