FDA recalls Sol-M syringes in BVI CustomEyes Procedure Packs
Beaver Visitec International is voluntarily recalling 133 units of BVI CustomEyes Procedure Packs containing Sol-M syringes manufactured by Sol-Millennium Medical. The Class II recall affects 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 a voluntary Class II medical device recall with no reported illnesses, injuries, or documented safety incidents in the source material. Voluntary precautionary recalls without reported harm are classified as Moderate severity.
Plain-English summary
Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. The recalled product is identified by Part Number 58002000, Lot Number 6071764, and UDI-DI 30886158034026.
The recall affects 133 units of the procedure packs that were distributed nationwide throughout the United States.
Healthcare providers and consumers who have received these procedure packs should contact Beaver Visitec International, Inc. for additional information and instructions regarding the recall and proper disposition of the product.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002000;
- Manufacturer
- Beaver Visitec International, Inc.
- Affected units
- 133
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: 58002000
- UDI-DI: 30886158034026
- Lot/Batch Number:6071764
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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