DeRoyal Dolphin Inflation Device Recalled for Sterility Assurance Defect
DeRoyal Industries is recalling 426 Dolphin Inflation Devices due to a primary packaging defect that may compromise sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class II recall. The hazard involves a lack of sterility assurance in a sterile medical device used in invasive procedures, which poses a significant risk of infection and potential serious injury.
Plain-English summary
DeRoyal Industries Inc is recalling 426 units of the DeRoyal(R) Dolphin Inflation Device, REF 0185ND. This medical device is indicated for use during angioplasty procedures to inflate and deflate balloon catheters and control pressure. The specific lot number is 15125173.
The recall was initiated because of a lack of sterility assurance. A defect in the primary packaging of the device may compromise the device's sterility. The affected units were distributed nationwide to Maryland, New York, and Illinois.
Healthcare providers and facilities that have received these devices should stop using them and contact DeRoyal Industries Inc for further instructions on the recall process.
The recalled product
- Product
- 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.
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device — Cardiovascular
- Affected units
- 426
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number 15125173
Distribution
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