FDA-Device2017-07-05Class II
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.
DeRoyal Industries Inc
Hazard
Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise the device sterility
Sold states
Nationwide Distribution to MD, NY, and IL
Affected count
426 units
Manufactured in
200 Debusk Ln, N/A, Powell, TN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2639-2017Don't want to check this manually?
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