The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2866-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs Recalled for Syringe Component Issue

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. The voluntary recall affects 196 units 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 is a voluntary, Class II medical device recall with no reported injuries, illnesses, or adverse events. It qualifies as a precautionary recall.

Plain-English summary

Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs due to a voluntary recall of syringe components manufactured by Sol-Millennium Medical (Sol-M), Inc. The affected procedure packs contain low dead space and luer slip tip 1ml syringes (Part Number 58001382, UDI-DI: 30886158024300).

The recall involves 196 units distributed nationwide. The affected lot numbers are 6068015, 6071277, and 6073797.

Healthcare facilities and consumers who have received these procedure packs should discontinue use and contact Beaver Visitec International for information on return or replacement of the affected products.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001382;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Ophthalmic Supplies
Hazard
Affected units
196

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: 58001382
  • UDI-DI: 30886158024300
  • Lot/Batch Number: 6068015
  • 6071277
  • 6073797

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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