Z-1828-2015Class II

Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit...

Name: Z-1828-2015 Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit...
Creator: Terumo Cardiovascular Systems Corp
Published: 2015-05-06
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2015-05-06 / Terminated / root cause: design

FDA source

Terumo Cardiovascular Systems Corp began a recall of Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for... on 2015-05-06. FDA classified it as Class II and gives the reason as "The Overpressure Safety Valve is not cleared with an indication for use on the arterial side of the extracoporeal bypass circuit. It is intended for use only on the venous side. There is a remote possibility of minimal...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1828-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-06
Posted: 2015-06-23
Terminated: 2015-07-27
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it.
Product code: DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Reason for recall: The Overpressure Safety Valve is not cleared with an indication for use on the arterial side of the extracoporeal bypass circuit. It is intended for use only on the venous side. There is a remote possibility of minimal blood loss, fluid weeping, or dripping on the user.
Root cause tag: design
FDA root cause: Component design/selection
Action: Consignees were notified of the recall by phone beginning on 5/7/2015 and a Urgent Medical Device Recall letter, dated 5/7/2015. The letter identified the affected device, reason for recall, potential hazard, and correction. Customers were asked to review the notice and ensure that all users are aware of the issue. In addition, they are to confirm the quantity of procedure kits for return; and, complete and return the Customer Response Form. Customers can call Terumo CVS Customer Service at 1-800-521-2818 with questions.
Quantity in commerce: 163 devices
Distribution: Distributed to the states of MO and FL.
Product codes and lots: Part Number: 66086-01: Lot Numbers: RG09, RM20 and Part Number: 70700-03: Lot Numbers: QL09, RH07, RL15, QG17, RD03

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1828-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1828-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-01	2015-06-22

Product code DTL

K820297Class IIWm. Harvey Overpressure Safety ValveC.R. Bard, Inc. / cleared 1982-03-12

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)