The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2931-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs containing Sol-M syringes recalled

Beaver Visitec International recalls CustomEyes Procedure Packs because they contain Sol-Millennium Medical syringes subject to a voluntary recall. Fourteen 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 Class II medical device recall involving syringes with no reported illnesses or injuries. The source does not specify the underlying hazard. The recall is voluntary in nature. According to the rubric, recalls with theoretical or unspecified hazards and no reported harm are classified as Moderate (score 2).

Plain-English summary

BVI CustomEyes Procedure Packs are being recalled due to the inclusion of syringes manufactured by Sol-Millennium Medical (Sol-M) that are subject to a voluntary recall. The affected procedure packs contain low dead space syringes and luer slip tip syringes with Part Number 58001973. Affected lot numbers include 6071751 and 6072074, with a total of 14 units distributed nationwide in the United States.

Consumers and healthcare facilities with affected procedure packs should refer to the FDA recall notice for further instructions.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001973;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Ophthalmic surgical equipment
Hazard
Affected units
14

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: 58001973
  • UDI-DI: 30886158034002
  • Lot/Batch Number: 6071751
  • 6072074

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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