The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2922-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs with Sol-M syringes recalled nationwide

Beaver Visitec recalled BVI CustomEyes Procedure Packs containing Sol-M syringes in a voluntary recall. 19 units were 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 recall with no reported illnesses or injuries and no specific hazard detailed in the source. It meets the rubric criteria for a voluntary precautionary recall (Moderate severity).

Plain-English summary

Beaver Visitec International, Inc. issued a voluntary recall of BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. The affected procedure packs contain low dead space and luer slip tip 1ml syringes with Part Number 58001876 and Lot Number 6069398 (UDI-DI: 30886158033234).

A total of 19 units of the procedure packs were involved in this recall. The procedure packs were distributed nationwide throughout the United States.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001876;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Surgical Supplies / Syringes
Affected units
19

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: 58001876
  • UDI-DI: 30886158033234
  • Lot/Batch Number: 6069398

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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