BVI CustomEyes Procedure Packs Recalled Due to Syringe Manufacturer Issue
Beaver Visitec International voluntarily recalls specific CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. No injuries or illnesses have been reported.
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 with no reported illnesses or injuries. While a Class II medical device, the specific defect or hazard is not detailed in the source material. Per the severity rubric, voluntary precautionary recalls without reported harm are classified as Moderate.
Plain-English summary
BVI CustomEyes Procedure Packs are being recalled because they contain syringes that are subject to a voluntary recall issued by the manufacturer, Sol-Millennium Medical (Sol-M), Inc. The procedure packs contain low dead space Luer Lock and Luer Slip 1ml syringes.
The recall affects 58 units distributed nationwide in the United States. The affected procedure packs are identified by Part Number 58000120, UDI-DI 30886158009512, and Lot Number 6071452.
No injuries or illnesses have been reported. Consumers and healthcare providers who have received the affected procedure packs should stop using them and contact Beaver Visitec International for instructions on replacement or return of the products.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000120;
- Manufacturer
- Beaver Visitec International, Inc.
- Hazard
- Affected units
- 58
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: 58000120
- UDI-DI: 30886158009512
- Lot/Batch Number: 6071452
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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