The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2893-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs Containing Sol-M Syringes Recalled Nationwide

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs that contain Sol-M syringes due to a voluntary recall by the syringe manufacturer. The recall affects 170 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 an FDA Class II voluntary precautionary recall with no reported illnesses, injuries, or adverse events disclosed in the source. Per the severity rubric, voluntary recalls without reported harm are typically classified as Moderate.

Plain-English summary

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes are being recalled. The affected product is identified by Part Number 58001629, with UDI-DI 30886158031773 and Lot/Batch Number 6061298. A total of 170 units have been distributed nationwide.

These procedure packs contain syringes manufactured by Sol-Millennium Medical (Sol-M), Inc., which has issued a voluntary recall for its low dead space and luer slip tip syringes. Beaver Visitec International initiated this voluntary recall of the affected BVI CustomEyes Procedure Packs containing these recalled syringes.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001629;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Syringes
Affected units
170

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: 58001629
  • UDI-DI: 30886158031773
  • Lot/Batch Number: 6061298

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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