Z-1465-2014Class II

Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431

Name: Z-1465-2014 Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431
Creator: Terumo Cardiovascular Systems Corp
Published: 2014-03-28
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2014-03-28 / Terminated / root cause: labeling and UDI

FDA source

Terumo Cardiovascular Systems Corp began a recall of Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431 on 2014-03-28. FDA classified it as Class II and gives the reason as "Incorrect customer notification label applied to the Tyvek lid of this specific lot of Terumo Cardiovascular Procedure Kits". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1465-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-28
Posted: 2014-04-16
Terminated: 2014-12-12
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431
Product code: OEZ Cardiovascular Procedure Kit
Reason for recall: Incorrect customer notification label applied to the Tyvek lid of this specific lot of Terumo Cardiovascular Procedure Kits
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Terumo CVS contacted the affected user on 3/28/14 by phone via phone script to discontinue use and return all affected units in inventory. Terumo CVS will replace or issue credit for returned product.
Quantity in commerce: 37 units
Distribution: CA
Product codes and lots: Lot Number: RA-27

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1465-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1465-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-23	2014-04-16

Product code OEZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)