FDA Recalls BVI CustomEyes Procedure Pack Syringes from Sol-M
The FDA is recalling BVI CustomEyes Procedure Packs due to a voluntary recall by Sol-M of syringes within them. The affected product (Part Number 58001423, Lot 6062969) was 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: This is a Class II FDA recall initiated as a voluntary precautionary action by the syringe manufacturer. No illnesses, injuries, or deaths are reported in the source material, and the specific hazard is not detailed.
Plain-English summary
BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical (Sol-M), Inc., are being recalled. The affected product is identified by Part Number 58001423 and Lot Number 6062969. Approximately 90 units were distributed nationwide throughout the United States.
The recall was initiated due to a voluntary action by Sol-M, Inc., regarding low dead space and luer slip tip syringes they manufactured. The specific reason for the recall has not been detailed in the available recall information.
Individuals and healthcare facilities who possess these packs should verify their inventory against the part number and lot number. For instructions on managing the recalled product, contact Beaver Visitec International, the manufacturer of the BVI CustomEyes Procedure Packs.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001423;
- Manufacturer
- Beaver Visitec International, Inc.
- Category
- Medical Device — Ophthalmic
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: 58001423
- UDI-DI: 30886158024027
- Lot/Batch Number: 6062969
Distribution
Distributed nationwide across the United States.
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