The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2807-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs Containing Sol-M Syringes Recalled

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs that contain syringes manufactured by Sol-Millennium Medical, Inc., due to a voluntary recall of those syringes. The recall affects 154 units 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: FDA Class II medical device recall with voluntary status. No illnesses or injuries are reported in the source, and the specific nature of the defect is not detailed.

Plain-English summary

Beaver Visitec International (BVI) is recalling BVI CustomEyes Procedure Packs (Part Number 58000426) because they contain syringes manufactured by Sol-Millennium Medical, Inc. (Sol-M), which Sol-M has voluntarily recalled. The affected syringes are low dead space luer lock and luer slip 1ml syringes.

The recall affects approximately 154 units distributed nationwide in the United States. The affected lot number is 6069170, and the product is identified by UDI-DI 30886158019894.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000426;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Ophthalmology Supplies
Hazard
Affected units
154

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: 58000426
  • UDI-DI: 30886158019894
  • Lot/Batch Number: 6069170

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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