BVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Defect
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M syringes due to a voluntary recall of the syringe components.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 described as a voluntary recall of syringes without explicit reports of injury or illness in the source text, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Beaver Visitec International, Inc. is recalling 80 units of BVI CustomEyes Procedure Packs, Part Number 58000508. 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 affected 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 6070809, and the UDI-DI is 30886158018552. Healthcare facilities and consumers should stop using these specific procedure packs and contact the recalling firm 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: 58000508;
- Manufacturer
- Beaver Visitec International, Inc.
- Category
- Medical Device — Syringes
- Hazard
- Affected units
- 80
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: 58000508
- UDI-DI: 30886158018552
- Lot/Batch Number: 6070809
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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