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.
Hazard
Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise the device sterility
What You Should Do
Remedy
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.
Affected by this recall?
Get a free legal consultation about this recall.
Talk to a Lawyer →Affiliate link
Products
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
- Brand
- DeRoyal Industries Inc
- UPC
- Lot Number 15125173
Units Affected
426 units