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: Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise the device sterility

Code information: Lot Number 15125173

Distribution pattern: Nationwide Distribution to MD, NY, and IL