BVI CustomEyes Procedure Packs Recalled for Defective Sol-M Syringes
BVI CustomEyes Procedure Packs containing Sol-M syringes have been voluntarily recalled. Users of affected packs should discontinue use and contact the 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 a voluntary precautionary recall with no reported illnesses, injuries, or hospitalizations. FDA Class II medical device recalls without reported adverse events are classified as Moderate severity.
Plain-English summary
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes (Part Number 58001521, Lot 6071460) are subject to a voluntary recall. Approximately 20 units were distributed nationwide in the United States.
The recall was initiated following a voluntary recall by Sol-Millennium Medical (Sol-M), Inc., the manufacturer of the syringes contained in these procedure packs. The specific defect or hazard associated with the syringes is not detailed in this recall notice.
Healthcare facilities and providers who received affected procedure packs should discontinue use and contact Beaver Visitec International, Inc. for further instructions.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001521;
- 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: 58001521
- UDI-DI: 30886158024690
- Lot/Batch Number: 6071460
Distribution
Distributed nationwide across the United States.
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