Cardiovascular Custom Procedure Kits, REV: 1 REV: 1A COATED FX PK Item Number: 72985-02 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.
FDA Recall Z-3246-2011 · Posted 2011-09-16
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Recalling FirmTerumo Cardiovascular Systems Corp
Recall StatusTerminated
Product CodeMJJ
Date Initiated2011-08-11
Date Terminated2012-03-20
Product Quantity325 units
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
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide Distribution, including the states of FL and MI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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