BVI CustomEyes Procedure Packs Containing Sol-M Syringes Recalled Nationwide
Beaver Visitec International is recalling 880 units of BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-M, Inc., distributed nationwide in the United States.
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 medical device recall initiated voluntarily as a precautionary measure. No illnesses, injuries, or hospitalizations have been reported in the source material.
Plain-English summary
Beaver Visitec International is voluntarily recalling 880 units of BVI CustomEyes Procedure Packs that contain syringes manufactured by Sol-M, Inc. The affected lots include 6069376, 6070126, and 6073273 (Part Number 58001113). These procedure packs have been distributed nationwide in the United States.
The recall affects low dead space and luer slip tip syringes produced by Sol-M, Inc. that are included in some BVI CustomEyes Procedure Packs. The manufacturer has initiated this voluntary recall, though the specific defect or hazard associated with these syringes has not been detailed in the agency notification.
Healthcare providers and patients who have received or used these procedure packs should contact Beaver Visitec International for information on product replacement or return procedures. The product is identified by Part Number 58001113 and the specific lot numbers listed above.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001113;
- Manufacturer
- Beaver Visitec International, Inc.
- Category
- Medical Device — Procedure Kit
- Hazard
- Affected units
- 880
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 (5)
- Part Number: 58001113
- UDI-DI: 30886158023839
- Lot/Batch Number: 6069376
- 6070126
- 6073273
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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