Terumo Cardiovascular Systems Corp: Medical Device Recall in 2014 - (Recall #: Z-0160-2015)

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- Catalog Number:165720 and Catalog Number: 6375 Product Usage: 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: I ratio. Includes a Conducer Heat Exchanger and a MP4 Temperature & Pressure 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-0160-2015

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: 16579 ; Catalog 6375: 3256 units

Code Information:

Catalog Number: 165720 Lot Numbers: MDI5, MD15B, MD22, ME19, MP13. Manufacturing dates March 15, 20 I 0 through December 13, 20 I 0. Catalog Number: 6375 Lot Numbers: MD15, ME19, MPI3 Manufacturing dates March 15, 2010 through December 13, 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