Z-0071-2013Class II

Terumo Backplate Replacement CXFVR 1500 Holder The Flexible venous Reservoir is mounted on the...

Name: Z-0071-2013 Terumo Backplate Replacement CXFVR 1500 Holder The Flexible venous Reservoir is mounted on the...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2009-10-02
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2009-10-02 / Terminated / root cause: labeling and UDI

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Terumo Backplate Replacement CXFVR 1500 Holder The Flexible venous Reservoir is mounted on the Backplate/Holder and secures the flexible reservoir by... on 2009-10-02. FDA classified it as Class II and gives the reason as "Backplate reservoir holders were manufactured with an incorrect configuration of connector supports. The devices were manufactured and configured with two 3/8 inch and one inch connector supports instead of one 3/8 inch...". 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-0071-2013
Classification: Class II
Status: Terminated
Initiated: 2009-10-02
Posted: 2012-10-16
Terminated: 2013-01-29
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Backplate Replacement CXFVR 1500 Holder The Flexible venous Reservoir is mounted on the Backplate/Holder and secures the flexible reservoir by strategically placed mounting arms. Additionally, there are three port supports the user incorporates to position the lines that enter and exit the venous bag. The Backplate/Holder is designed to allow the user to move the port support location to accommodate different tubing circuit designs to permit mounting flexibility.
Product code: KRI Accessory Equipment, Cardiopulmonary Bypass
Reason for recall: Backplate reservoir holders were manufactured with an incorrect configuration of connector supports. The devices were manufactured and configured with two 3/8 inch and one inch connector supports instead of one 3/8 inch and two inch connector supports (See location of supports as # 7 and # 8 on backplate attachment). The backplates were manufactured as described in manufacturing instructions a
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: The firm, Terumo, interviewed the Sr. Product Manager from the Marketing Department of the company on August 29, 2012. The interview included the description of the product, problem and action taken. Replacement connectors were provided to users and all units were corrected. If you have any questions, call 734-663-4145 or Manager, Regulatory Affairs at 734-741-5576.
Quantity in commerce: 33 units
Distribution: Worldwide distribution: USA (nationwide) including states of: CA, MI, NC, NJ, PA, and WI;and country of: EUROPE.
Product codes and lots: No lot/serial number; Catalog number: PN 816280

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0071-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0071-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-24	2012-10-16

Product code KRI

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