Z-1535-2012

Terumo Custom Cardiovascular Procedure Kit- X-COATED PERFUSION PK FX15RE40

Name: Z-1535-2012 Terumo Custom Cardiovascular Procedure Kit- X-COATED PERFUSION PK FX15RE40
Creator: Terumo Cardiovascular Systems Corp
Published: 2012-04-12
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2012-04-12 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corp began a recall of Terumo Custom Cardiovascular Procedure Kit- X-COATED PERFUSION PK FX15RE40 Product Code:73673 Manufactured to the design and specifications of the... on 2012-04-12. The reason FDA records is "Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss". 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-1535-2012
Status: Terminated
Initiated: 2012-04-12
Posted: 2012-05-11
Terminated: 2013-01-23
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Custom Cardiovascular Procedure Kit- X-COATED PERFUSION PK FX15RE40 Product Code:73673 Manufactured to the design and specifications of the purchaser/user) for the application it is intended.
Product code: DTZ Oxygenator, Cardiopulmonary Bypass
Reason for recall: Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Terumo Cardiovascular Systems issued an Urgent Medical Device Recall notification on 4/12/12 to all user facilities/consignees who have received affected devices. The letter identified the affected product, stated the reason for the recall, the potential hazard involved, and the correction. Users are to review the letter, ensure that all users are made aware of the issue, discontinue use of the affected product, and return it to Terumo CVS. In addition, users are to return the response form to the manufacturer. Affected units will be replaced with new units. Contact Terumo CVS Customer Service @ 1-800-521-2818 or [email protected]
Quantity in commerce: 7 units
Distribution: Worldwide Distribution -- US, including the states of AL, AZ, CA, MO, and NY and the country of Canada.
Product codes and lots: Lot No: NA17

Product code DTZ

K071494Class IICapiox Fx15 and Fx25 Hollow Fiber Oxygenator and Arterial FilterTerumo Corp. / cleared 2007-07-16

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)