DeRoyal(R) Dolphin Inflation Device recall: Sterility Concern
DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an inflation device indicated during angioplasty procedures to…
Why was DeRoyal(R) Dolphin Inflation Device recalled?
Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise the device sterility
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number 15125173
- Product
- DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an inflation device indicated during angioplasty procedures to…
- Recalling firm
- DeRoyal Industries Inc
- Quantity
- 426 units
- Distribution
- Nationwide Distribution to MD, NY, and IL
- Recall date
- July 5, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)