Beaver Visitec recalls CustomEyes Procedure Packs with Sol-M syringes
Beaver Visitec International is voluntarily recalling 216 units of BVI CustomEyes Procedure Packs containing low dead space and luer slip tip syringes manufactured by Sol-M. The recall affects nationwide distribution.
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: FDA Class II medical device recall with voluntary nature. No specific hazard, defect, or adverse event reports are identified in the source notice. The rubric classifies voluntary precautionary recalls as Moderate (Score 2).
Plain-English summary
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs (Part Number 58001484) containing low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. The recall affects 216 units with lot numbers 6061631 and 6062125, distributed nationwide. The unique device identifier (UDI-DI) is 30886158024133.
This is a voluntary recall. The notice provided does not specify a hazard, defect, or adverse event associated with the affected syringes.
Healthcare professionals and facilities that have received these procedure packs should verify lot numbers against inventory to identify affected units. No further action guidance from the FDA or manufacturer is provided in the recall notice.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001484;
- Manufacturer
- Beaver Visitec International, Inc.
- Category
- Medical Device
- Affected units
- 216
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 (4)
- Part Number: 58001484
- UDI-DI: 30886158024133
- Lot/Batch Number: 6061631
- 6062125
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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