Vascular Solutions Recalls Dolphin Inflation Devices Due to Sterile Barrier Defect
Vascular Solutions, Inc. is recalling 4,110 Dolphin Inflation Devices due to a potential sterile barrier defect that could lead to microbial contamination and infection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of harm (infection from microbial contamination) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Vascular Solutions, Inc. is recalling 4,110 units of the Dolphin Inflation Device (REF 0185NA) due to a potential defect in the sterile barrier. The device is a single-use, sterile inflation tool used in cardiovascular procedures to pressurize and depressurize balloon catheters. The recall was initiated by the manufacturer, Perouse Medical.
The affected products were distributed in the United States, including Puerto Rico, and specifically to the states of Louisiana, Tennessee, California, South Carolina, Oregon, Washington, Oklahoma, Nevada, Hawaii, Ohio, and Texas. The recall covers specific lot numbers: 15075668, 15075924, 15115426, 15125175, 16025324, 16035493, and 16055261.
Use of the affected devices could pose a risk of microbial contamination, which may lead to infection. Healthcare providers and facilities should stop using these devices and contact the manufacturer for further instructions.
The recalled product
- Product
- Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide. DOLPHIN is a single-use, sterile inflation device used in cardiovascular procedures to pressurize (inflate) and depressurize (deflate) balloon catheters. The device itself consists of two compo
- Manufacturer
- Vascular Solutions, Inc.
- Category
- Medical Device — Cardiovascular
- Affected units
- 4,110
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 (7)
- Lot Numbers: 15075668
- 15075924
- 15115426
- 15125175
- 16025324
- 16035493
- 16055261.
Distribution
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