The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2794-2024·Announced 2024-09-04

FDA Recalls CustomEyes Procedure Packs with Sol-M Syringes

Beaver Visitec International voluntarily recalls CustomEyes Procedure Packs containing Sol-M syringes, affecting 84 units distributed nationwide. The specific hazard was not detailed in the recall notice.

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: This is a voluntary recall of medical device syringes classified as FDA Class II, with no reported illnesses, injuries, hospitalizations, or deaths. No specific hazard was detailed in the recall notice, consistent with voluntary precautionary recalls.

Plain-English summary

Beaver Visitec International, Inc. is voluntarily recalling CustomEyes Procedure Packs (Part Number 58000023) that contain low dead space Luer Lock and Luer Slip 1ml syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. The recall affects 84 units with lot number 6073123 that were distributed nationwide in the United States.

The recall was initiated due to a voluntary recall by Sol-M, the syringe manufacturer. The specific nature of the defect or concern was not detailed in the FDA's recall announcement.

Customers who have received the affected CustomEyes Procedure Packs should discontinue use and contact Beaver Visitec International for further instructions regarding the recall. The FDA has classified this as a Class II recall.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000023;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Syringes
Affected units
84

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: 58000023
  • UDI-DI: 30886158009253
  • Lot/Batch Number: 6073123

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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