Recall Z-2639-2017— DeRoyal Industries Inc

Name: FDA recall Z-2639-2017
Creator: U.S. Food and Drug Administration
Published: 2017-06-07

Class II · Terminated

Class II FDA medical device recall by DeRoyal Industries Inc, initiated 2017-06-07, terminated 2020-07-22. It names one FDA 510(k) clearance: K042449. 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: Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise the device sterility.

Recalling firm: DeRoyal Industries Inc
Classification: Class II
Status: Terminated
Initiated: 2017-06-07
Terminated: 2020-07-22
Firm location: Powell, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K042449 — DOLPHIN INFLATION DEVICESedat S.A.·cleared 2005-04-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.