DeRoyal Industries Inc recalls DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an inflation device indicated during a…

Recall date

June 7, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2639-2017

FDA classification

Class II

Brand / firm

DeRoyal Industries Inc

Sold / distributed

Nationwide Distribution to MD, NY, and IL

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.