Z-0157-2015 Class II Terminated
FDA device recall Z-0157-2015 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: 165 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
- 165 units
Product Description
Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 Item Number: 16110 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
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: ML13, MM04. Manufacturing datese September 13, 2010 through October 4, 20 I 0.