Procedure packs with Sol-Millennium syringes subject to voluntary recall
BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes are being voluntarily recalled. Approximately 198 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: FDA Class II voluntary precautionary recall. The source does not specify a hazard or report any illnesses or injuries, consistent with Level 2 (Moderate) severity for precautionary voluntary recalls.
Plain-English summary
BVI CustomEyes Procedure Packs containing Sol-Millennium Medical (Sol-M) Luer Lock and Luer Slip 1ml syringes (Part Number 58000056) are being voluntarily recalled. The syringe components are manufactured by Sol-Millennium Medical, Inc.
Approximately 198 units were distributed nationwide. The affected products were manufactured under lot/batch numbers 6065306 and 6069372, with UDI-DI 30886158008980.
Patients and healthcare facilities using affected procedure packs should contact Beaver Visitec International, Inc. for further instructions and return procedures.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000056;
- 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 (4)
- Part Number: 58000056
- UDI-DI: 30886158008980
- Lot/Batch Number: 6065306
- 6069372
Distribution
Distributed nationwide across the United States.
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