The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2841-2024·Announced 2024-09-04

Voluntary Recall of Sol-M Syringes in BVI CustomEyes Procedure Packs

Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes. The recall affects 23 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 voluntary FDA Class II medical device recall with no reported illnesses or injuries and no explicit hazard specified in the recall notice, consistent with a precautionary recall.

Plain-English summary

Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs (Part Number 58001054) that contain Sol-Millennium Medical (Sol-M) manufactured low dead space syringes and luer slip tip syringes. These procedure packs have UDI-DI 30886158022078 and lot number 6071307.

This is a voluntary recall of syringes manufactured by Sol-M that are present in some BVI CustomEyes Procedure Packs. The recalled procedure packs were distributed nationwide in the United States. A total of 23 units are affected by this recall.

Healthcare providers and facilities that have received these procedure packs should stop using the affected products immediately and contact Beaver Visitec International, Inc. or the FDA with questions or concerns about this recall.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001054;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Syringes / Procedure Packs
Hazard
Affected units
23

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: 58001054
  • UDI-DI: 30886158022078
  • Lot/Batch Number:6071307

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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