BVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Design
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M 1ml syringes distributed nationwide. The syringes contain specific design features that prompted the recall.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a voluntary precautionary recall of a Class II medical device with no reported illnesses or injuries. The source text does not specify the nature of the hazard, making this a theoretical risk with no documented patient harm.
Plain-English summary
Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs that contain 1ml syringes manufactured by Sol-Millennium Medical, Inc. (Sol-M). The affected product has Part Number 58001118 and was distributed nationwide throughout the United States.
The recall was initiated due to issues with the low dead space and luer slip tip design characteristics of the Sol-M syringes contained in these procedure packs. As a Class II medical device recall, this action was taken on a voluntary basis by the manufacturer.
Healthcare facilities and providers who have received these procedure packs should discontinue use of the affected syringes. Individuals should contact Beaver Visitec International, Inc. for instructions on return, replacement, or proper disposition of the recalled products.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001118;
- Manufacturer
- Beaver Visitec International, Inc.
- Hazard
- Affected units
- 5
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)
- Part Number: 58001118
- UDI-DI: 30886158022238
- Lot/Batch Number: 6070127
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 159 recalled by Beaver Visitec International, 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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