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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo Custom Kit

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  Class 2 Device Recall Terumo Custom Kit see related information
Date Initiated by Firm June 08, 2010
Date Posted August 02, 2010
Recall Status1 Terminated 3 on May 07, 2012
Recall Number Z-2162-2010
Recall Event ID 56037
510(K)Number K823451  
Product Classification Cardiovascular Procedure Kit - Product Code DTR
Product Terumo Cardiovascular Procedure Kit Custom
P/N: 70608-01

Code Information Lot: ME19
Recalling Firm/
Terumo Cardiovascular Systems Corp
28 Howe St
Ashland MA 01721-1305
For Additional Information Contact SAME
800-283-7866 Ext. 7420
Manufacturer Reason
for Recall
Vent port may be occluded and prevent delivery of fluid
FDA Determined
Cause 2
Equipment maintenance
Action Terumo, Ashland, MA notified consignees on 6/8/10, by phone, fax, email and mail to advise distributors and end-users of the required recall actions. Follow-up communication sent by priority overnight mail on 6/9/10, with proof of delivery, specifying the awareness to the issue and necessary correction activities should a unit be discovered. Phase 2 initiated on 7/1/10 to sale rep to remove recalled product and perform a product reconciliation to ensure that all affected product is identified, returned to Terumo CVS, and that replacement product is sent immediately.
Quantity in Commerce 40 packs
Distribution Distribution USA 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 = DTR and Original Applicant = 3M HEALTH CARE, SARNS