Terumo Cardiovascular Systems Corp: Medical Device Recall in 2014 - (Recall #: Z-0159-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Terumo Custom Cardiovascular and Perfusion Procedure Kits Catalog Codes: Kits with a 5-digit code beginning with the digit 6: Catalog Number: 6XXXX ; Catalog Codes: Kits with a 5-digit code beginning with the digit 7: Catalog Number: 7XXXX Product usage: The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery. 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.

Product Classification:

Class II

Date Initiated: March 1, 2011

Date Posted: November 12, 2014

Recall Number: Z-0159-2015

Event ID: 58185

Reason for Recall:

Defect in the luer connector can compromise the seal on the female side of the connector and the compromised seal can introduce air in the table line.

Status: Terminated

Product Quantity: Catalog Number: 6XXXX: 4561 units; Catalog Number: 7xxxx : 19356 units

Code Information:

Catalog Number: 6XXXX Lot Numbers: ML07, MM18, MM25, MN08, MN IS, MN22. Manufacturing dates September 7, 20 I 0 through November 22, 20 I 0. Catalog Number: 7XXXX Lot Numbers: ML07,ML20, MM18, MM25, MNO1, MN08, MN15, MN29,MP06, MP13. Manufacturing dates September 7, 2010 through December 13,2010.

Distribution Pattern:

Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.

Voluntary or Mandated:

Voluntary: Firm initiated