Vascular Solutions Recalls Guardian II Hemostasis Valves Due to Missing Seals
Vascular Solutions, Inc. is recalling Guardian II Hemostasis Valves because some pouches are missing a seal, posing a risk of product contamination.
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 3/5 (High).
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 product contamination in a medical device where no specific injuries or illnesses have been reported, fitting the criteria for a high-risk product with theoretical harm.
Plain-English summary
Vascular Solutions, Inc. is recalling the Guardian II Hemostasis Valve (Model 8210) and Guardian II NC Hemostasis Valve (Model FH102). The recall involves 3,500 units from lots 27686, 27293, and 22446. These devices are intended to maintain hemostasis during the use of diagnostic and interventional devices.
The recall was initiated because the company became aware of a potential problem where pouches are missing a seal. This defect poses a risk of product contamination. The affected products were distributed worldwide, including nationwide in the United States and in Italy and Korea.
Healthcare providers and consumers should stop using the affected devices and contact Vascular Solutions, Inc. for further instructions or a replacement.
The recalled product
- Product
- Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve, Model FH102. Intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside…
- Manufacturer
- Vascular Solutions, Inc.
- Hazard
- Affected units
- 3,500
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 (3)
- lots 27686
- 27293
- 22446
Distribution
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