BVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringes
Beaver Visitec International is recalling 214 BVI CustomEyes Procedure Packs containing Sol-M syringes due to a voluntary recall of the syringe components.
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: The recall is classified as FDA Class II and is a voluntary precautionary recall initiated by the component manufacturer. The source text does not report any illnesses, injuries, or specific hazards associated with the syringes, fitting the criteria for a moderate severity score.
Plain-English summary
Beaver Visitec International, Inc. is recalling 214 units of BVI CustomEyes Procedure Packs, Part Number 58000287. These procedure packs contain Sol-M Luer Lock and Luer Slip 1ml syringes manufactured by Sol-Millennium Medical (Sol-M), Inc.
The recall is being conducted because Sol-Millennium Medical is voluntarily recalling low dead space syringes and luer slip tip syringes. The Sol-M syringes are present in some of the BVI CustomEyes Procedure Packs.
The affected products were distributed nationwide in the United States. The specific lot number is 6073793, and the UDI-DI is 30886158013182. Users should stop using these procedure packs and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000287;
- Manufacturer
- Beaver Visitec International, Inc.
- Category
- Medical Device — Syringes
- Hazard
- Affected units
- 214
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: 58000287
- UDI-DI: 30886158013182
- Lot/Batch Number: 6073793
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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