The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2869-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled Nationwide

Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M syringes manufactured by Sol-Millennium Medical, Inc. Approximately 70 units have been 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 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 Class II medical device recall with no reported illnesses or injuries stated in the source. The voluntary classification and absence of documented harm align with the rubric criterion for voluntary precautionary recalls, yielding a Moderate severity score.

Plain-English summary

BVI CustomEyes Procedure Packs containing Sol-M (Sol-Millennium Medical, Inc.) syringes are being voluntarily recalled. The affected product consists of procedure packs containing low dead space and luer slip tip 1ml syringes, identified by Part Number 58001411.

The recall affects 70 units that have been distributed nationwide in the United States. The affected product carries UDI-DI: 30886158023914 and Lot/Batch Number: 6064644.

This is a voluntary Class II recall issued by Beaver Visitec International, Inc., as determined by the FDA (Medical Devices division). Consumers or healthcare facilities who have received this product should consult the manufacturer or healthcare provider for further information regarding the recall.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001411;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Surgical and procedure supplies
Hazard
Affected units
70

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: 58001411
  • UDI-DI: 30886158023914
  • Lot/Batch Number: 6064644

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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