The Recall Desk
HighFDA (Devices)·Z-2797-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs Recalled for Sol-M Syringe Components

Beaver Visitec International voluntarily recalls BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. The recall affects 351 units distributed nationwide.

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 with no reported illnesses or injuries mentioned in the source text. It qualifies as a risk-of-harm product category where no actual harm has been reported, consistent with a High severity rating.

Plain-English summary

Beaver Visitec International, Inc. has issued a voluntary recall of BVI CustomEyes Procedure Packs (Part Number 58000126) that contain syringes manufactured by Sol-Millennium Medical, Inc.

The recalled procedure packs contain low dead space syringes and luer slip tip syringes produced by Sol-M. The affected batches are 6061650 and 6072066, with 351 total units of this product distributed across the United States. The product can be identified using UDI-DI 30886158009307.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000126;
Manufacturer
Beaver Visitec International, Inc.
Hazard
  • syringe-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 (4)

  • Part Number: 58000126
  • UDI-DI: 30886158009307
  • Lot/Batch Number: 6061650
  • 6072066

Distribution

Distributed nationwide across the United States.