FDA recall Z-2639-2017

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.

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

Nationwide Distribution to MD, NY, and IL

Key facts

Status

Terminated

Initiation date

2017-06-07

Report date

2017-07-05

Termination date

2020-07-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Powell, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2639-2017