Recall Z-3245-2011 ยท MJJ Cpb Check Valve, Retrograde Flow, In-Line
Terumo Cardiovascular Systems Corp
Cardiovascular Custom Procedure Kits, REV: 0, REV: 1 REV: 4, REV: 6A, REV: 6B. REV: 6C COATED FX PK Item Number: 72985-01 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 dur
| Date | Sep 16, 2011 (initiated Aug 11, 2011) |
| Status | Terminated |
| Reason | 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 | 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 | 818 units |
| Distribution | Nationwide Distribution, including the states of FL and MI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001245 | 3T L. V. CONTROL VALVE 3t Medical Systems, LLC, Aug 15, 2001 |