The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2863-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs with Sol-M syringes recalled

BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes are being voluntarily recalled by the FDA. The affected 1ml Luer Lock and Luer Slip syringes 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: FDA Class II recall with no reported illnesses or injuries documented in the source. The specific hazard is not described in the recall notice, and the recall is voluntary rather than mandated.

Plain-English summary

Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs (Part Number 58001375) that contain syringes manufactured by Sol-Millennium Medical (Sol-M). The recalled procedure packs include 1ml Luer Lock and Luer Slip syringes and were distributed nationwide in the United States.

The FDA has classified this as a Class II recall. The recall notice does not specify the underlying hazard or defect associated with the affected syringes.

Healthcare providers and consumers who have received affected procedure packs should discontinue use. Those with Lot Number 6058779, Part Number 58001375, should contact Beaver Visitec International, Inc. for instructions on returning the product.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001375;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Ophthalmic / Surgical Syringes
Hazard
Affected units
30

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: 58001375
  • UDI-DI: 30886158024379
  • Lot/Batch Number: 6058779

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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