—#103456

Product

Cardiovascular Custom Procedure Kits, REV : 2, REV: 4 FX, CP50,CENT Pack Item Number: 73386 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 product code: MJJ — Cpb Check Valve, Retrograde Flow, In-Line
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K001245
Affected lot / code info: Lot Numbers: ME19 MG14 MH19

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Terumo Cardiovascular Systems Corp
Address: 28 Howe St, Ashland, Massachusetts 01721-1305

Distribution

Distribution pattern: Nationwide Distribution, including the states of FL and MI.

Timeline

Recall initiated: 2011-08-11
Posted by FDA: 2011-09-16
Terminated: 2012-03-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #103456. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.