Z-2251-2016 Class II Terminated
FDA device recall Z-2251-2016 was initiated by BEST THERATRONICS LTD. on May 6, 2016 and is designated Class II. Reason for recall: It was discovered that both the new device and the predicate device failed to comply with performance standard. The recall status is terminated (terminated August 1, 2017). Affected quantity: 128.
Recall Details
- Product Type
- Devices
- Report Date
- August 3, 2016
- Initiation Date
- May 6, 2016
- Termination Date
- August 1, 2017
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 128
Product Description
Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease.
Reason for Recall
It was discovered that both the new device and the predicate device failed to comply with performance standard.
Distribution Pattern
Nationwide
Code Information
All Raycell units with serial #'s 5000 and higher.