BVI CustomEyes Procedure Packs Containing Sol-M Syringes Recalled
Beaver Visitec International is recalling 1,238 units of BVI CustomEyes Procedure Packs containing Sol-M syringes. The recall is voluntary and affects procedure packs 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 Class II FDA medical device recall has no reported injuries or illnesses and is described as voluntary. Voluntary precautionary recalls without incident reports are classified as Moderate severity.
Plain-English summary
Beaver Visitec International, Inc. is recalling 1,238 units of BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes (Part Number 58001123). These procedure packs are distributed nationwide and are used in ophthalmologic procedures.
The affected procedure packs contain syringes manufactured by Sol-Millennium Medical (Sol-M), Inc., which initiated a voluntary recall. The specific lots affected are 6047610, 6049448, and 6050478 (UDI-DI: 30886158022467).
If you have these procedure packs, contact Beaver Visitec International, Inc. for further 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: 58001123;
- Manufacturer
- Beaver Visitec International, Inc.
- Hazard
- Affected units
- 1,238
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: 58001123
- UDI-DI: 30886158022467
- Lot/Batch Number: 6047610
- 6049448
- 6050478
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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