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.
FDA Recall Z-2639-2017 · Posted None
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Recalling FirmDeRoyal Industries Inc
Recall StatusTerminated
Product CodeMAV
Date Initiated2017-06-07
Date Terminated2020-07-22
Product Quantity426 units
Reason for Recall
Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise the device sterility
Firm Action
DeRoyal issued an Urgent Recall Notice dated June 7, 2017, to all affected customers. The customers were asked to identify the affected products and return the provided notice of return form back to DeRoyal indicating if replacement or credit is requested. Customers with questions were instructed to call 888-938-7828 or email [email protected].
For questions regarding this recall call 865-938-7828.
Root Cause
Unknown/Undetermined by firm
Distribution Pattern
Nationwide Distribution to MD, NY, and IL
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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