BVI CustomEyes Procedure Packs recalled for Sol-M manufactured syringe component
Beaver Visitec International voluntarily recalls 2,117 BVI CustomEyes Procedure Packs that contain Sol-M manufactured syringes. The syringes are part of a voluntary recall initiated by the syringe manufacturer.
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: Classified as FDA Class II voluntary recall with no reported injuries or illnesses. Per the rubric, voluntary precautionary recalls fall into the Moderate (2) category.
Plain-English summary
Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs that contain syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. The recalled procedure packs contain Sol-M Luer Lock and Luer Slip 1ml syringes with Part Number 58000628. Approximately 2,117 units have been distributed nationwide.
The procedure packs were distributed throughout the United States. Healthcare providers and other recipients of these products should stop using them and contact Beaver Visitec International for further instructions.
This recall was initiated following a voluntary recall of the same syringes by Sol-Millennium Medical, the syringe manufacturer.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000628;
- Manufacturer
- Beaver Visitec International, Inc.
- Affected units
- 2,117
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 (4)
- Part Number: 58000628
- UDI-DI: 30886158019627
- Lot/Batch Number: 6069204
- 6074036
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.
See all 159 products in this recall →Related recalls
Same manufacturer · Beaver Visitec International, Inc.
See all →- ModerateLaser and endoscopy systems recalled over ferrites omitted from a USB cable
FDA (Devices) · 2026-01-07
- ModerateBVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringes
FDA (Devices) · 2024-09-04
- ModerateBVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Issue
FDA (Devices) · 2024-09-04
- ModerateBVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Issue
FDA (Devices) · 2024-09-04
- ModerateBVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Issue
FDA (Devices) · 2024-09-04