Z-3247-2011

Cardiovascular Custom Procedure Kits, REV: 2A, REV: 2B X-COATED FX PK Item Number: 73191 Terumo...

Name: Z-3247-2011 Cardiovascular Custom Procedure Kits, REV: 2A, REV: 2B X-COATED FX PK Item Number: 73191 Terumo...
Creator: Terumo Cardiovascular Systems Corp
Published: 2011-08-11
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2011-08-11 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corp began a recall of Cardiovascular Custom Procedure Kits, REV: 2A, REV: 2B X-COATED FX PK Item Number: 73191 Terumo Cardiovascular Systems, Ashland, MA 01721 The Cardiovascular... on 2011-08-11. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3247-2011
Status: Terminated
Initiated: 2011-08-11
Posted: 2011-09-16
Terminated: 2012-03-20
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Cardiovascular Custom Procedure Kits, REV: 2A, REV: 2B X-COATED FX PK Item Number: 73191 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.
Product code: MJJ Cpb Check Valve, Retrograde Flow, In-Line
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
Root cause tag: manufacturing process
FDA 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 in commerce: 160 units
Distribution: Nationwide Distribution, including the states of FL and MI.
Product codes and lots: Lot Numbers: MM11 MN15 MP20

Product code MJJ

K001245Class II3T L. V. Control Valve3t Medical Systems, LLC / cleared 2001-08-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)