The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2797-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs Recalled for Sol-M Syringe Components

Beaver Visitec International voluntarily recalls BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. The recall affects 351 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 3/5 (High).

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 illnesses or injuries mentioned in the source text. It qualifies as a risk-of-harm product category where no actual harm has been reported, consistent with a High severity rating.

Plain-English summary

Beaver Visitec International, Inc. has issued a voluntary recall of BVI CustomEyes Procedure Packs (Part Number 58000126) that contain syringes manufactured by Sol-Millennium Medical, Inc.

The recalled procedure packs contain low dead space syringes and luer slip tip syringes produced by Sol-M. The affected batches are 6061650 and 6072066, with 351 total units of this product distributed across the United States. The product can be identified using UDI-DI 30886158009307.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000126;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Surgical Instruments / Syringes
Hazard
Affected units
351

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 (4)

  • Part Number: 58000126
  • UDI-DI: 30886158009307
  • Lot/Batch Number: 6061650
  • 6072066

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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