The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2904-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs with Sol-M Syringes Subject to Voluntary Recall

Beaver Visitec International is voluntarily recalling 200 units of BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes distributed nationwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 voluntary Class II medical device recall involves no reported illnesses, injuries, or deaths. It meets the criterion for moderate severity as a voluntary precautionary recall without documented patient harm.

Plain-English summary

Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs (Part Number 58001706, Lot 6074000) that contain 1ml syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. The recalled procedure packs contain both Luer Lock and Luer Slip tip syringe variants. A total of 200 units were distributed nationwide.

This is a Class II recall issued by the U.S. Food and Drug Administration. The source material does not specify the particular defect or hazard associated with the recalled syringes.

Healthcare facilities and consumers that have received these procedure packs should discontinue use and contact Beaver Visitec International for instructions on returns or replacements. Healthcare providers should verify their inventory for Part Number 58001706 and Lot Number 6074000.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001706;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Ophthalmic Procedure Kit
Hazard
Affected units
200

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: 58001706
  • UDI-DI: 30886158032473
  • Lot/Batch Number: 6074000

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 →

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