—#156207

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.

FDA product code: MAV — Syringe, Balloon Inflation
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K042449
Affected lot / code info: Lot Number 15125173

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

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

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 recalls@deroyal.com. For questions regarding this recall call 865-938-7828.

Recalling firm

Firm: DeRoyal Industries Inc
Address: 200 Debusk Ln, Powell, Tennessee 37849-4703

Distribution

Distribution pattern: Nationwide Distribution to MD, NY, and IL

Timeline

Recall initiated: 2017-06-07
Terminated: 2020-07-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #156207. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.