BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled
BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes are subject to a voluntary recall. The recall affects 9 units distributed nationwide.
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 with no reported illnesses or injuries and no stated hazard in the source text. It is characterized as a voluntary recall, which fits the 'voluntary precautionary recalls' criterion for a Moderate severity rating.
Plain-English summary
Beaver Visitec International, Inc. is issuing a voluntary recall of BVI CustomEyes Procedure Packs (Part Number 58001073) containing syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. The affected packs contain low dead space Luer Lock and Luer Slip 1ml syringes.
The recall affects 9 units distributed nationwide in the United States. Affected products can be identified by Lot/Batch Number 6070760 and UDI-DI 30886158021934.
This is a voluntary recall of the Sol-M manufactured syringes by their maker. The specific reason for the recall is not provided in this notice.
Customers who have received these procedure packs are advised to contact Beaver Visitec International, Inc. or their supplier for further information and instructions regarding the recall.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001073;
- Manufacturer
- Beaver Visitec International, Inc.
- Category
- Medical Device — Syringes
- Hazard
- Affected units
- 9
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: 58001073
- UDI-DI: 30886158021934
- Lot/Batch Number: 6070760
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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