Reported Jul 5, 2017 · Terminated
DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an inflation device indicated during…
DeRoyal Industries Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DeRoyal Industries Inc · 200 Debusk Ln · Powell, TN · 37849-4703
Is this the product you have?
- 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.
- Lot codes and dates
- Lot Number 15125173
- Amount recalled
- 426 units
Where it was sold
Why it was recalled
Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise the device sterility
This product could cause temporary or reversible health problems — stop using it.
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