FDAFDA · Food and drugs·Recall number Z-2639-2017
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.
Published July 5, 2017 · Recall initiated: June 7, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise the device sterility
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- DeRoyal Industries Inc
- Distributor
- Nationwide Distribution to MD, NY, and IL
- Lot
- Lot Number 15125173
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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