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DeRoyal Industries Inc recalls DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an inflation device indicated during
Recalled July 5, 2017 · FDA recall Z-2639-2017 · DeRoyal Industries
Hazard
Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise the device sterility · FDA Class II
Units
426 units
Sold at
Nationwide Distribution to MD, NY, and IL
Description
Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise the device sterility
Product
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.
Manufacturer(s)
DeRoyal Industries Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →