Z-0159-2015 Class II Terminated
FDA device recall Z-0159-2015 was initiated by Terumo Cardiovascular Systems Corp on March 1, 2011 and is designated Class II. 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. The recall status is terminated (terminated November 6, 2014). Affected quantity: Catalog Number: 6XXXX: 4561 units; Catalog Number: 7xxxx : 19356 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 12, 2014
- Initiation Date
- March 1, 2011
- Termination Date
- November 6, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Catalog Number: 6XXXX: 4561 units; Catalog Number: 7xxxx : 19356 units
Product Description
Terumo Custom Cardiovascular and Perfusion Procedure Kits Catalog Codes: Kits with a 5-digit code beginning with the digit 6: Catalog Number: 6XXXX ; Catalog Codes: Kits with a 5-digit code beginning with the digit 7: Catalog Number: 7XXXX Product usage: The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it.
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.
Distribution Pattern
Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.
Code Information
Catalog Number: 6XXXX Lot Numbers: ML07, MM18, MM25, MN08, MN IS, MN22. Manufacturing dates September 7, 20 I 0 through November 22, 20 I 0. Catalog Number: 7XXXX Lot Numbers: ML07,ML20, MM18, MM25, MNO1, MN08, MN15, MN29,MP06, MP13. Manufacturing dates September 7, 2010 through December 13,2010.