Recall Z-2639-2017 ยท MAV Syringe, Balloon Inflation
DeRoyal Industries Inc
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.
| Date | Jun 7, 2017 |
| Status | Terminated |
| Reason | Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise the device sterility |
| Root cause | Unknown/Undetermined by 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 recalls@deroyal.com. For questions regarding this recall call 865-938-7828. |
| Quantity | 426 units |
| Distribution | Nationwide Distribution to MD, NY, and IL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042449 | DOLPHIN INFLATION DEVICE Sedat S.A., Apr 18, 2005 |