BVI CustomEyes Procedure Packs with Sol-M Syringes Subject to Voluntary Recall
BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes are subject to a voluntary recall distributed nationwide. The recalled packs contain low dead space luer lock and luer slip 1ml syringes.
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 voluntary recall with no reported illnesses or injuries. The specific hazard is not detailed in the recall notice, consistent with a precautionary voluntary recall.
Plain-English summary
Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes. The recalled syringes, manufactured by Sol-Millennium Medical (Sol-M), Inc., are present in some of the BVI CustomEyes Procedure Packs (Part Number 58001943, Lot 6071510). This is a voluntary recall, and the affected procedure packs were distributed nationwide in the United States.
The FDA classifies this as a Class II recall. The specific reason for the recall or recommended consumer actions are not provided in the FDA recall notice. Patients and healthcare providers who have questions about this recall should contact the manufacturer, Beaver Visitec International, Inc.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001943;
- Manufacturer
- Beaver Visitec International, Inc.
- Category
- Medical Device — Syringes
- Hazard
- device-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: 58001943
- UDI-DI: 30886158033623
- Lot/Batch Number: 6071510
Distribution
Distributed nationwide across the United States.
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