Recall Z-2639-2017
DeRoyal Industries Inc · initiated June 7, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot Number 15125173
Reason for recall
Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise the device sterility
FDA-determined cause: Unknown/Undetermined by firm
Action taken
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.
Details
- Recall number
- Z-2639-2017
- Initiated
- June 7, 2017
- Terminated
- July 22, 2020
- Product code
- MAV – Syringe, Balloon Inflation
- Quantity
- 426 units
- Distribution
- Nationwide Distribution to MD, NY, and IL
- Recalling firm
- DeRoyal Industries Inc, Powell, TN