The Recall Desk
ModerateFDA (Devices)·Z-2853-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled

Beaver Visitec is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes. Approximately 77 units were 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 a voluntary precautionary recall with no reported illnesses or injuries. The source does not specify the underlying manufacturing issue, consistent with the FDA's Class II classification and precautionary nature of the recall.

Plain-English summary

BVI CustomEyes Procedure Packs are being recalled because they contain low dead space and luer slip tip 1ml syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. that are subject to recall. The affected product is identified by Part Number 58001212, UDI-DI 30886158022818, and Lot Number 6072094. Approximately 77 units were distributed nationwide.

This is a voluntary recall being conducted by Beaver Visitec International, Inc. in conjunction with Sol-M's recall of the affected syringe types. Specific details regarding the reason for the syringe recall have not been disclosed in this notice.

Healthcare providers and facilities that have received these CustomEyes Procedure Packs should stop using them and contact Beaver Visitec International for instructions on return or replacement. For more information, refer to FDA recall number Z-2853-2024.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001212;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Ophthalmic / Surgical Procedure Pack
Hazard
Affected units
77

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: 58001212
  • UDI-DI: 30886158022818
  • Lot/Batch Number: 6072094

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.

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Same hazard · syringe defect

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