The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2804-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs with Sol-M syringes voluntarily recalled

BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes have been voluntarily recalled. The recall affects 124 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 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: FDA Class II voluntary medical device recall with no documented illnesses or injuries reported in the source. The voluntary precautionary nature indicates a moderate risk level.

Plain-English summary

BVI CustomEyes Procedure Packs containing low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical, Inc. (Sol-M) have been voluntarily recalled. These ophthalmic procedure packs were distributed nationwide, with 124 units affected by this recall.

The affected procedure packs can be identified by Part Number 58000288, Lot Number 6069388, and UDI-DI 30886158013496.

If you have received these procedure packs, stop using them and contact Beaver Visitec International, Inc. for instructions on the recall and replacement options.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000288;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Ophthalmic Procedure Pack
Hazard
Affected units
124

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: 58000288
  • UDI-DI: 30886158013496
  • Lot/Batch Number: 6069388

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 →

Related recalls

Same manufacturer · Beaver Visitec International, Inc.

See all →

Same hazard · syringe defect

See all →

Similar recalls