Z-0160-2015 Class II Terminated
FDA device recall Z-0160-2015 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: 16579 ; Catalog 6375: 3256 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: 16579 ; Catalog 6375: 3256 units
Product Description
Terumo Custom Cardioplegia Delivery Set- Catalog Number:165720 and Catalog Number: 6375 Product Usage: 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: I ratio. Includes a Conducer Heat Exchanger and a MP4 Temperature & Pressure 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
Catalog Number: 165720 Lot Numbers: MDI5, MD15B, MD22, ME19, MP13. Manufacturing dates March 15, 20 I 0 through December 13, 20 I 0. Catalog Number: 6375 Lot Numbers: MD15, ME19, MPI3 Manufacturing dates March 15, 2010 through December 13, 20 I 0