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.
Reported: July 5, 2017 Initiated: June 7, 2017 #Z-2639-2017
Product Description
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.
Reason for Recall
Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise the device sterility
Details
- Recalling Firm
- DeRoyal Industries Inc
- Units Affected
- 426 units
- Distribution
- Nationwide Distribution to MD, NY, and IL
- Location
- Powell, TN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by DeRoyal Industries Inc. Units affected: 426 units.
Why was this product recalled? ▼
Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise the device sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 5, 2017. Severity: Moderate. Recall number: Z-2639-2017.
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