Z-2639-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 5, 2017
- Initiation Date
- June 7, 2017
- Termination Date
- July 22, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 426 units
Product Description
DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an inflation device indicated during angioplasty procedures to inflate and deflate the balloon catheter, and control pressure.
Reason for Recall
Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise the device sterility
Distribution Pattern
Nationwide Distribution to MD, NY, and IL
Code Information
Lot Number 15125173