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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-2154-2010
Recall Event ID 56037
510(K)Number K823451  
Product Classification Cardiovascular Procedure Kit - Product Code DTR
Product Terumo Cardiovascular Procedure Kit Custom
P/N 71546-01

Code Information Lots: MF03
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 4 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