BVI CustomEyes Procedure Packs recalled for containing Sol-M syringes
Beaver Visitec International is recalling 1,955 units of BVI CustomEyes Procedure Packs nationwide because they contain Sol-M syringes subject to a voluntary recall by the manufacturer.
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 an FDA Class II recall initiated as a voluntary recall with no reported illnesses or injuries. The rubric explicitly classifies voluntary precautionary recalls as Moderate severity. While syringes used in medical procedures represent potential risk-of-harm products, the precautionary nature and absence of reported harm support a Moderate designation.
Plain-English summary
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes are being recalled. The affected procedure packs have Part Number 58001019 and include lot/batch numbers 6069184, 6069624, and 6075235. Approximately 1,955 units were distributed nationwide.
These syringes were manufactured by Sol-Millennium Medical (Sol-M), Inc. and are subject to a voluntary recall initiated by the manufacturer. The syringes are included in some BVI CustomEyes Procedure Packs.
Healthcare facilities and providers who have received these procedure packs should stop using the affected lots and contact Beaver Visitec International for instructions on how to return or replace the recalled products.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001019;
- Manufacturer
- Beaver Visitec International, Inc.
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 (5)
- Part Number: 58001019
- UDI-DI: 30886158022566
- Lot/Batch Number: 6069184
- 6069624
- 6075235
Distribution
Distributed nationwide across the United States.
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