Halyard Convenience Kits Recalled Due to Particulates in Manifolds
AVID Medical, Inc. is recalling Halyard convenience kits containing Medline Namic Angiographic Star Off Handle Manifolds because particulates may be present in the fluid path.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The recall is classified as FDA Class I, which indicates a situation where there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Plain-English summary
AVID Medical, Inc. is recalling Halyard convenience kits that contain Medline Namic Angiographic Star Off Handle Manifolds. This recall affects 5,168 kits distributed nationwide in North Carolina and Texas.
The recall was initiated because particulates may be present within the fluid path of the manifolds. These particulates have the potential to be introduced into blood circulation and become lodged within blood vessels.
Users should check their inventory for the affected lots and follow manufacturer instructions regarding the recalled products.
The recalled product
- Product
- Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. SAMMC ANGIOGRAPHY SAMM066-15
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 5,168
Distribution
Part of a larger recall action
This product is one of 3 recalled by AVID Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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