BVI CustomEyes Procedure Packs Containing Sol-M Syringes Recalled
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical. The voluntary recall affects 29 units 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 medical device recall with no reported illnesses, injuries, or deaths. The recall is voluntary and precautionary in nature, consistent with FDA criteria for voluntary precautionary recalls.
Plain-English summary
Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs containing low dead space and luer slip tip syringes with Part Number 58001695. These syringes were manufactured by Sol-Millennium Medical, Inc. (Sol-M) and included in some of BVI's procedure packs.
The affected procedure packs have been distributed nationwide throughout the United States. A total of 29 units are included in this recall, with UDI-DI 30886158031957 and Lot/Batch Number 6062796.
This is a voluntary recall. Healthcare providers and facilities that have received these procedure packs should discontinue use and contact Beaver Visitec International for further instructions regarding the return or disposal of the affected product.
The U.S. Food and Drug Administration (FDA) has classified this as a Class II medical device recall (Recall Number Z-2902-2024).
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001695;
- Manufacturer
- Beaver Visitec International, Inc.
- 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: 58001695
- UDI-DI: 30886158031957
- Lot/Batch Number: 6062796
Distribution
Distributed nationwide across the United States.
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