The Recall Desk
HighFDA (Devices)·Z-2792-2024·Announced 2024-09-04

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

Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M syringes distributed nationwide. The recall affects 35 units with Part Number 584770 and is classified as FDA Class II.

What this means for you

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 medical device recall involving surgical syringes with an unspecified defect. Although the recall is voluntary and no adverse events have been reported, medical syringes used in ophthalmic procedures represent a risk of patient harm if they malfunction. This fits the rubric criteria of 'risk-of-harm products where injury has not yet been reported,' warranting a High severity classification.

Plain-English summary

Beaver Visitec International, Inc. has voluntarily recalled BVI CustomEyes Procedure Packs that contain syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. The affected procedure packs incorporate Luer Lock and Luer Slip 1ml syringes and are identified by Part Number 584770 and Lot Number 6067190. Approximately 35 units were distributed nationwide in the United States.

This is an FDA Class II voluntary recall. The BVI CustomEyes Procedure Packs are subject to recall due to the inclusion of Sol-M syringes that are themselves the subject of a recall.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584770;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Surgical Syringes
Hazard
Affected units
35

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: 584770
  • UDI-DI:30886158008973
  • Lot/Batch Number: 6067190

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 →