Z-2639-2017 Class II Terminated
FDA device recall Z-2639-2017 was initiated by DeRoyal Industries Inc on June 7, 2017 and is designated Class II. Reason for recall: Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise the device sterility The recall status is terminated (terminated July 22, 2020). Affected quantity: 426 units.
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