Z-0156-2015 Class II Terminated
FDA device recall Z-0156-2015 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: 596 units; 876 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
- 596 units; 876 units
Product Description
Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, 16010 Product Usage: This is a Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to deliver blood/solutions at a 4:1 ratio. In includes a Conducer Heat Exchanger and a Bubble Trap module. Additionally, the set is constructed with a female luer connector that is the subject of the 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
Item Number: 58520-Lot Numbers: MF24, MM11, MN01. Manufacturing dates May 24, 20 I 0 through November I, 2010 Item Number: 1610-Lot Numbers: MM11, MN08, MNI5, MN29 MP07. Manufacturing dates October 11, 20 I 0 through December 7, 20 I 0