BVI CustomEyes Procedure Packs With Sol-M Syringes Recalled Voluntarily
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs that contain syringes manufactured by Sol-Millennium Medical due to a voluntary recall by the syringe manufacturer.
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 recall initiated voluntarily by the manufacturer. No illnesses, injuries, or deaths are reported in the source material. Voluntary precautionary recalls without reported adverse events are classified as Moderate per the severity rubric.
Plain-English summary
BVI CustomEyes Procedure Packs containing low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. are being recalled. The affected packs are identified by Part Number 58001526 (UDI-DI 30886158031476, Lot 6070130) and have been distributed nationwide in the United States.
Beaver Visitec International, Inc. initiated this voluntary recall following a recall of the component syringes by their manufacturer, Sol-Millennium Medical.
Healthcare facilities using these packs should contact Beaver Visitec International, Inc. for information and instructions regarding this recall.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001526;
- Manufacturer
- Beaver Visitec International, Inc.
- Hazard
- Affected units
- 35
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: 58001526
- UDI-DI: 30886158031476
- Lot/Batch Number: 6070130
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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