Cardiovascular Custom Procedure Kits, REV.0, REV 1, REV 1A, REV. 2 XCoated 8:1 FX PACK Item Number: 73192 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.
This recall has been terminated (originally issued September 16, 2011).
- Recall Initiated
- August 11, 2011
- Posted
- September 16, 2011
- Terminated
- March 20, 2012
- Recall Number
- Z-3232-2011
- Quantity
- 180 units
- Firm Location
- Ashland, MA
- Official Source
- View on FDA website ↗
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
Distribution
Nationwide Distribution, including the states of FL and MI.
Lot / Code Info
Lot Numbers: ML20 MM11 MN15 MP20 NA24 NC21 ND14 NF02 NG06 NG13
Root Cause
Nonconforming Material/Component
Action Taken
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.