Voluntary Recall of BVI CustomEyes Procedure Packs With Sol-M Syringes
BVI voluntarily recalls CustomEyes Procedure Packs because they contain syringes recalled by their manufacturer, Sol-Millennium Medical, Inc. Approximately 94 units were distributed nationwide.
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 an FDA Class II recall conducted voluntarily by the manufacturer. No illnesses, injuries, or deaths are reported. The recall is precautionary in nature without a specified hazard, matching the rubric criteria for voluntary precautionary recalls.
Plain-English summary
BVI CustomEyes Procedure Packs (Part Number 58000910) are being voluntarily recalled due to the inclusion of 1ml syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These Sol-M syringes are subject to a separate recall initiated by the manufacturer.
Approximately 94 units of the affected procedure packs were distributed to customers across the United States. The affected lot is identified by Batch Number 6062356 and UDI-DI 30886158021545.
BVI is conducting this voluntary recall in response to the manufacturer's recall of the Sol-M syringes contained in the procedure packs. Healthcare providers and customers who have received these procedure packs should contact BVI CustomEyes or their distributor for further information and guidance regarding the recalled products.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000910;
- Manufacturer
- Beaver Visitec International, Inc.
- Hazard
- manufacturing-defect
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: 58000910
- UDI-DI: 30886158021545
- Lot/Batch Number: 6062356
Distribution
Distributed nationwide across the United States.
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