Recall Z-0158-2015
Terumo Cardiovascular Systems Corp · initiated March 1, 2011
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Lot Numbers: MN08, MNI5, MM11, MM18, MM25. Manufacturing dates October 1I, 2010 through Novemberl5, 20 I 0.
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
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-0158-2015
- Initiated
- March 1, 2011
- Posted by FDA
- October 31, 2014
- Terminated
- November 6, 2014
- Product code
- DTR – Heat-Exchanger, Cardiopulmonary Bypass
- Quantity
- 777 units
- Distribution
- Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.
- Recalling firm
- Terumo Cardiovascular Systems Corp, Ashland, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0156-2015 Class II | Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item…Defect in the luer connector can compromise the seal on the female side of the connector and the compromised… | 03/01/2011Terminated |
| Z-0157-2015 Class II | Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 Item…Defect in the luer connector can compromise the seal on the female side of the connector. and the… | 03/01/2011Terminated |
| Z-0159-2015 Class II | Terumo Custom Cardiovascular and Perfusion Procedure Kits Catalog Codes: Kits with a…Defect in the luer connector can compromise the seal on the female side of the connector and the compromised… | 03/01/2011Terminated |
| Z-0160-2015 Class II | Terumo Custom Cardioplegia Delivery Set- Catalog Number:165720 and Catalog Number: 6375…Defect in the luer connector can compromise the seal on the female side of the connector. and the… | 03/01/2011Terminated |
| Z-0161-2015 Class II | Terumo Custom Cardioplegia Delivery Sets Catalog Code: 204880 Product Usage: This is a…Defect in the luer connector can compromise the seal on the female side of the connector and the compromised… | 03/01/2011Terminated |