Terumo Cardiovascular Systems Corp: Medical Device Recall in 2014 - (Recall #: Z-0158-2015)

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 Cardioplegia Delivery Set- Item Number: 16130 Product Usage: The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery.

Product Classification:

Class II

Date Initiated: March 1, 2011

Date Posted: November 12, 2014

Recall Number: Z-0158-2015

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: 777 units

Code Information:

Lot Numbers: MN08, MNI5, MM11, MM18, MM25. Manufacturing dates October 1I, 2010 through Novemberl5, 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