Date Initiated by Firm | August 11, 2011 |
Date Posted | September 16, 2011 |
Recall Status1 |
Terminated 3 on March 20, 2012 |
Recall Number | Z-3251-2011 |
Recall Event ID |
59704 |
510(K)Number | K001245 |
Product Classification |
Cardiovascular, Cpb Check Valve, Retrograde Flow, In-line - Product Code MJJ
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Product | Cardiovascular Custom Procedure Kits, REV: 3, REV: 3A, REV:4
FX, CP50 CENT. PK
Item Number: 73386-01
Terumo Cardiovascular Systems, Ashland, MA 01721
The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart. |
Code Information |
Lot Numbers: MM25 NA17 NC07 ND28 NE11 NF31 |
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 | 3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | Terumo Cardiovascular Systems initiated contact on August 12, 2011 by phone, fax, email and Urgent: Medical Device Recall mail to all affected customers.
The firm advised customers of the affected product, problem and required recall actions. Customers can remove whole customized packs that are not in urgent medical need and return packs. Or the User may opt to use a sterile LH 130 vent valve from Terumo Cardiovascular Systems. A response form was included to return back to the firm.
For questions on this recall contact Terumo Customer Service at (734) 525-9580. |
Quantity in Commerce | 96 units |
Distribution | Nationwide Distribution, including the states of FL and MI. |
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 = MJJ
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