The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2901-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs Recalled for Defective Syringes

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs that contain Sol-M syringes due to a manufacturer's voluntary recall. The nationwide recall affects Luer Lock and Luer Slip 1ml syringes in the procedure packs.

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 voluntary recall with no reported injuries or illnesses and no specific hazard described in the source material. This qualifies as a voluntary precautionary recall per the severity rubric.

Plain-English summary

Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs that contain syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. Specifically, the recalled packs contain Sol-M Luer Lock and Luer Slip 1ml syringes (Part Number 58001693) distributed nationwide.

This recall is due to a voluntary recall of the Sol-M syringes by the manufacturer. The affected product has Lot Number 6062795 and UDI-DI 30886158031971.

Healthcare providers and facilities using these procedure packs should verify whether they have the recalled lot in their inventory. Contact Beaver Visitec International for instructions on return or replacement of the affected packs.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001693;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Surgical Equipment
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: 58001693
  • UDI-DI: 30886158031971
  • Lot/Batch Number: 6062795

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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