The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2798-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs Recalled for Defective Sol-M Syringes

Beaver Visitec International voluntarily recalled BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. The recall affects 69 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 recall affecting medical devices used in surgical procedures. FDA Class II indicates products where use may cause temporary or medically reversible adverse health consequences. Although the recall was voluntary and no illnesses or injuries have been reported, defective syringes in surgical procedures represent a risk-of-harm situation.

Plain-English summary

Beaver Visitec International, Inc. has voluntarily recalled BVI CustomEyes Procedure Packs containing low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical, Inc. The affected procedure packs are identified by Part Number 58000162, with lot numbers 6065820 and 6071739 and a UDI-DI of 30886158018675.

A total of 69 units were distributed nationwide. The source documentation does not specify the nature of the defect in the Sol-M syringes or any reported adverse events.

Healthcare facilities and providers that received these procedure packs should contact Beaver Visitec International for recall instructions and information on replacement products or corrective actions.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000162;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Ophthalmology Procedure Packs
Hazard
Affected units
69

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: 58000162
  • UDI-DI: 30886158018675
  • Lot/Batch Number: 6065820
  • 6071739

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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