FDA Recalls CustomEyes Procedure Packs with Sol-M Syringes
Beaver Visitec International voluntarily recalls CustomEyes Procedure Packs containing Sol-M syringes, affecting 84 units distributed nationwide. The specific hazard was not detailed in the recall notice.
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 recall of medical device syringes classified as FDA Class II, with no reported illnesses, injuries, hospitalizations, or deaths. No specific hazard was detailed in the recall notice, consistent with voluntary precautionary recalls.
Plain-English summary
Beaver Visitec International, Inc. is voluntarily recalling CustomEyes Procedure Packs (Part Number 58000023) that contain low dead space Luer Lock and Luer Slip 1ml syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. The recall affects 84 units with lot number 6073123 that were distributed nationwide in the United States.
The recall was initiated due to a voluntary recall by Sol-M, the syringe manufacturer. The specific nature of the defect or concern was not detailed in the FDA's recall announcement.
Customers who have received the affected CustomEyes Procedure Packs should discontinue use and contact Beaver Visitec International for further instructions regarding the recall. The FDA has classified this as a Class II recall.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000023;
- Manufacturer
- Beaver Visitec International, Inc.
- Category
- Medical Device — Syringes
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: 58000023
- UDI-DI: 30886158009253
- Lot/Batch Number: 6073123
Distribution
Distributed nationwide across the United States.
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