Z-0158-2015 Class II Terminated
FDA device recall Z-0158-2015 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: 777 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
- 777 units
Product Description
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.
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
Lot Numbers: MN08, MNI5, MM11, MM18, MM25. Manufacturing dates October 1I, 2010 through Novemberl5, 20 I 0.