Skip to content

Terumo Custom Cardioplegia Delivery Set - Heat Exchanger… recallZ-0156-2015 · Terumo Cardiovascular Systems Corp · initiated Mar 1, 2011

Class II Terminated All recalls posted in October 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Terumo Cardiovascular Systems Corp or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Device Design

What the company is doing

Terumo Cardiovascualr notified accounts by letter dated 3/1/2011 advising users users that the luer connector to the table line in certain lots of myocardial protection sets may leak. Users should not continue to use affected myocardial protection sets in a manner that exposes the connector to negative pressure without taking correction or replacement activities as described. Firm provided mitigating instructions: Clamp the table line distal to the luer connector when ending an infusion of cardioplegia thus isolating the leak from negative pressure. Contact Terumo CVS Customer Service to report the defect and arrange return of the unit: 800-521-2818.

Recall details

Recall number
Z-0156-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Mar 1, 2011
Posted by the FDA
Oct 31, 2014
Recalling firm
Terumo Cardiovascular Systems Corp
Quantity
596 units; 876 units
Product code
DTR
FDA submissions
K900640
Distribution
Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.

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

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

2 devices cleared under K900640 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 58185).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page