The Recall Desk
HighFDA (Devices)·Z-2886-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs containing Sol-M Syringes Recalled Nationwide

Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M-manufactured syringes. The recall affects 138 units distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall with no reported injuries, illnesses, or deaths. Under the rubric, FDA Class II without hospitalization reports corresponds to a High rating, particularly given that syringes are medical delivery devices with inherent risk if defective, though the specific defect is not detailed in the source.

Plain-English summary

BVI CustomEyes Procedure Packs containing Sol-M syringes (Part Number 58001579) are being voluntarily recalled by Beaver Visitec International, Inc. The recall affects 138 units distributed nationwide.

The packs contain low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical, Inc. The affected product lot is 6074019, identifiable by UDI-DI 30886158031575.

This is classified by the FDA as a Class II recall. The public recall announcement does not specify details of the underlying issue prompting the recall.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001579;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Ophthalmic Equipment
Hazard
Affected units
138

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: 58001579
  • UDI-DI: 30886158031575
  • Lot/Batch Number: 6074019

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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Same manufacturer · Beaver Visitec International, Inc.

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