The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2820-2024·Announced 2024-09-04

Syringes in BVI CustomEyes Procedure Packs subject to voluntary recall

Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs that contain syringes manufactured by Sol-Millennium Medical. The FDA has classified this as a Class II medical device recall.

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 classified as FDA Class II but with no reported injuries or illnesses. The source characterizes this as a voluntary precautionary recall with no specific hazard or defect details provided. The score reflects the absence of reported harm and the voluntary, precautionary nature of the recall.

Plain-English summary

BVI CustomEyes Procedure Packs containing low dead space and Luer Slip 1ml syringes manufactured by Sol-Millennium Medical, Inc. are subject to a voluntary recall. The affected products are identified by Part Number 58000749, UDI-DI 30886158020258, and Lot Number 6071465. Approximately 101 units of these packs were distributed nationwide throughout the United States.

Beaver Visitec International, Inc., the manufacturer, initiated the voluntary recall following a recall of these syringes by their supplier, Sol-Millennium Medical, Inc. The FDA has classified this as a Class II medical device recall.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000749;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Syringes
Affected units
101

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: 58000749
  • UDI-DI: 30886158020258
  • Lot/Batch Number: 6071465

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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