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Terminated

Terumo Custom Cardioplegia Delivery Sets Catalog Code: 204880 Product Usage: This is a replacement line to multiple Cardioplegia Delivery Sets-and includes the female luer connector" that is the subject of this correction/removal activity

FDA Recall Z-0161-2015 · Posted 2014-10-31

Recalling FirmTerumo Cardiovascular Systems Corp
Recall StatusTerminated
Product CodeDTR
Date Initiated2011-03-01
Date Terminated2014-11-06
Product Quantity24 units

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

Firm Action

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.

Root Cause

Device Design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K897039SARNS MINIPRIME CARDIOPLEGIA SET W/CONDUCER(TM)3M Company · 1990-03-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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