BVI CustomEyes Procedure Packs with Sol-M syringes recalled
BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes are being voluntarily recalled by the FDA. The affected 1ml Luer Lock and Luer Slip syringes 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 recall with no reported illnesses or injuries documented in the source. The specific hazard is not described in the recall notice, and the recall is voluntary rather than mandated.
Plain-English summary
Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs (Part Number 58001375) that contain syringes manufactured by Sol-Millennium Medical (Sol-M). The recalled procedure packs include 1ml Luer Lock and Luer Slip syringes and were distributed nationwide in the United States.
The FDA has classified this as a Class II recall. The recall notice does not specify the underlying hazard or defect associated with the affected syringes.
Healthcare providers and consumers who have received affected procedure packs should discontinue use. Those with Lot Number 6058779, Part Number 58001375, should contact Beaver Visitec International, Inc. for instructions on returning the product.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001375;
- 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 (3)
- Part Number: 58001375
- UDI-DI: 30886158024379
- Lot/Batch Number: 6058779
Distribution
Distributed nationwide across the United States.
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