Syringes in BVI CustomEyes Procedure Packs subject to voluntary recall
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs that contain syringes manufactured by Sol-Millennium Medical. The FDA has classified this as a Class II medical device 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 classified as FDA Class II but with no reported injuries or illnesses. The source characterizes this as a voluntary precautionary recall with no specific hazard or defect details provided. The score reflects the absence of reported harm and the voluntary, precautionary nature of the recall.
Plain-English summary
BVI CustomEyes Procedure Packs containing low dead space and Luer Slip 1ml syringes manufactured by Sol-Millennium Medical, Inc. are subject to a voluntary recall. The affected products are identified by Part Number 58000749, UDI-DI 30886158020258, and Lot Number 6071465. Approximately 101 units of these packs were distributed nationwide throughout the United States.
Beaver Visitec International, Inc., the manufacturer, initiated the voluntary recall following a recall of these syringes by their supplier, Sol-Millennium Medical, Inc. The FDA has classified this as a Class II medical device recall.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000749;
- Manufacturer
- Beaver Visitec International, Inc.
- Category
- Medical Device — Syringes
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: 58000749
- UDI-DI: 30886158020258
- Lot/Batch Number: 6071465
Distribution
Distributed nationwide across the United States.
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