The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2916-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs with Sol-M Syringes Subject to Voluntary Recall

Beaver Visitec International voluntarily recalls BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. The affected syringes are low dead space and luer slip tip models 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 voluntary medical device recall with no reported illnesses or injuries. Per the severity rubric, voluntary precautionary recalls are classified as Moderate (2).

Plain-English summary

Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs that contain low dead space and luer slip tip 1ml syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. The affected procedure packs are Part Number 58001818, Lot Number 6075189.

These procedure packs were distributed nationwide in the United States, with 65 units involved in this recall. The recall is voluntary and initiated due to a concurrent recall of the Sol-M syringes contained within the procedure packs.

The specific reason for the syringe recall has not been specified in the public announcement. Further information regarding this recall is available from the FDA and Beaver Visitec International.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001818;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Ophthalmic
Hazard
Affected units
65

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: 58001818
  • UDI-DI: 30886158033180
  • Lot/Batch Number: 6075189

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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