Terumo Cardiovascular Systems Corp: Medical Device Recall in 2014 - (Recall #: Z-0156-2015)

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 Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, 16010 Product Usage: This is a Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to deliver blood/solutions at a 4:1 ratio. In includes a Conducer Heat Exchanger and a Bubble Trap module. Additionally, the set is constructed with a female luer connector that is the subject of the correction/removal activity

Product Classification:

Class II

Date Initiated: March 1, 2011

Date Posted: November 12, 2014

Recall Number: Z-0156-2015

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: 596 units; 876 units

Code Information:

Item Number: 58520-Lot Numbers: MF24, MM11, MN01. Manufacturing dates May 24, 20 I 0 through November I, 2010 Item Number: 1610-Lot Numbers: MM11, MN08, MNI5, MN29 MP07. Manufacturing dates October 11, 20 I 0 through December 7, 20 I 0

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated