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U.S. Department of Health and Human Services

Class 2 Device Recall Stabilizer, Heart

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  Class 2 Device Recall Stabilizer, Heart see related information
Date Initiated by Firm January 05, 2015
Date Posted February 22, 2017
Recall Status1 Terminated 3 on February 23, 2017
Recall Number Z-1232-2017
Recall Event ID 76346
Product Classification stabilizer,heart - Product Code MWS
Product Titan" Stabilizer Attachment and Titan TM 360 Stabilizer
Attachment
Code Information Catalog Number: 401-231, Product Description: Titan" Stabilizer Attachment , Lot Number: 052R   Catalog Number 401-231u , Product Description TitanTM 360 Stabilizer Attachment , Lot Number: 020R, 024R, 026R, 029R, 030R,034R,035R,037R, 040 , 048R 
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corporation
125 Blue Ball Rd
Elkton MD 21921-5315
Manufacturer Reason
for Recall		 Terumo Cardiovascular Systems (Terumo CVS) is voluntarily recalling certain lots of Titan" Stabilizers and Titan" 360 Stabilizers because the Suction Tubing Clip may break when it is being attached to a Terumo CVS Hercules Stabilizing Arm. Although the clip is for convenience purposes and is not required for device operation, there is a potential for broken Suction Tubing Clip fragments to fall into the surgical site.
FDA Determined
Cause 2		 Other
Action A recall notification is being forwarded to all users and consignees who have received product. The notification of this voluntary recall will be sent to the following consignee in each facility:+ Director of Operating Room Services Proposed Level of Effectiveness Checks: Terumo CVS will verify that 100% of all letters are delivered to affected consignees
Quantity in Commerce 1463
Distribution The product was distributed domestically and also to foreign consignees. But not to government agency's or 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.
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