The Recall Desk
ModerateFDA (Devices)·Z-2808-2024·Announced 2024-09-04

BVI Recalls CustomEyes Procedure Packs Containing Recalled Sol-M Syringes

BVI is recalling CustomEyes Procedure Packs because they contain syringes subject to a separate voluntary recall by manufacturer Sol-Millennium Medical. The recall affects 217 units 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 Class II medical device recall without reported illnesses or injuries, and without specification of a particular hazard in the source material. It qualifies as a precautionary recall consistent with a Moderate severity classification.

Plain-English summary

Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs that contain Sol-Millennium Medical (Sol-M) brand syringes. The product is subject to a voluntary recall initiated due to the underlying syringes, which are part of the procedure packs distributed nationwide.

The recalled procedure packs contain Sol-M Luer Lock and Luer Slip 1ml syringes (Part Number 58000455, UDI-DI: 30886158018644, Lot/Batch Number: 6062130). A total of 217 units have been distributed throughout the United States.

Customers who have received affected procedure packs should contact the manufacturer for further information and instructions regarding the recall.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000455;
Manufacturer
Beaver Visitec International, Inc.
Hazard
  • device-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: 58000455
  • UDI-DI: 30886158018644
  • Lot/Batch Number: 6062130

Distribution

Distributed nationwide across the United States.