The Recall Desk
ModerateFDA (Devices)·Z-2819-2024·Announced 2024-09-04

Beaver Visitec Recalls Medical Device Syringes in CustomEyes Procedure Packs

Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs because they contain defective syringes manufactured by Sol-M. The 237 affected units were distributed nationwide.

What this means for you

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 FDA Class II medical device recall with no reported injuries or illnesses mentioned in the source text. The voluntary nature and absence of reported harm indicate moderate severity.

Plain-English summary

Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes.

The recalled syringes are identified by Part Number 58000711, UDI-DI 30886158020357, and Lot Number 6073236. A total of 237 units were distributed nationwide.

Patients and healthcare providers who have these procedure packs should discontinue use. Contact Beaver Visitec International for instructions on returns, replacements, or any other questions regarding this recall.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000711;
Manufacturer
Beaver Visitec International, Inc.
Hazard
  • manufacturing-defect

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: 58000711
  • UDI-DI: 30886158020357
  • Lot/Batch Number: 6073236

Distribution

Distributed nationwide across the United States.