BVI CustomEyes Procedure Packs Recalled for Sol-M Syringe Issue
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical, which are subject to a separate voluntary recall.
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 recall of FDA Class II medical devices with no reported illnesses, injuries, or specific hazard explanation provided in the source text. Voluntary precautionary recalls without evidence of reported harm are classified as Moderate.
Plain-English summary
Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs (Part Number 58001048, Lot 6069190) that contain 1ml syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. The recall was initiated because the syringes supplied by Sol-M are the subject of a separate voluntary recall.
The affected procedure packs were distributed nationwide in the United States. These packs contain both Sol-M Luer Lock and Luer Slip 1ml syringes.
Healthcare providers and consumers who have received these procedure 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: 58001048;
- Manufacturer
- Beaver Visitec International, Inc.
- Hazard
- Affected units
- 48
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: 58001048
- UDI-DI: 30886158022344
- Lot/Batch Number: 6069190
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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