Date Initiated by Firm | April 12, 2012 |
Date Posted | May 11, 2012 |
Recall Status1 |
Terminated 3 on January 23, 2013 |
Recall Number | Z-1530-2012 |
Recall Event ID |
61644 |
510(K)Number | K071494 |
Product Classification |
Oxygenator, cardiopulmonary bypass - Product Code DTZ
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Product | Terumo Custom Cardiovascular Procedure Kit-PEDIATRIC PACK
Product Code: 71062-01
Manufactured to the design and specifications of the purchaser/user) for the application it is intended. |
Code Information |
Lot No: MD29 ; ME26; MK02 ; NA17; NC14 ; NH05 ; NL12 ; NN28; PA09 |
Recalling Firm/ Manufacturer |
Terumo Cardiovascular Systems Corp 28 Howe St Ashland MA 01721-1305
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For Additional Information Contact | SAME 508-231-2400 |
Manufacturer Reason for Recall | Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | Terumo Cardiovascular Systems issued an Urgent Medical Device Recall notification on 4/12/12 to all user facilities/consignees who have received affected devices. The letter identified the affected product, stated the reason for the recall, the potential hazard involved, and the correction. Users are to review the letter, ensure that all users are made aware of the issue, discontinue use of the affected product, and return it to Terumo CVS. In addition, users are to return the response form to the manufacturer. Affected units will be replaced with new units. Contact Terumo CVS Customer Service @ 1-800-521-2818 or tcvs.recall@teruomedical.com |
Quantity in Commerce | 37 units |
Distribution | Worldwide Distribution -- US, including the states of AL, AZ, CA, MO, and NY and the country of Canada. |
Total Product Life Cycle | TPLC Device Report |
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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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510(K) Database | 510(K)s with Product Code = DTZ
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