BVI CustomEyes Procedure Packs with Sol-M Syringes Voluntary Recall
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes due to a voluntary manufacturer recall of those components.
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 Class II medical device recall with no reported illnesses, injuries, or hospitalizations mentioned in the source material. The specific hazard rationale is not detailed in the provided text.
Plain-English summary
Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs that contain low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. The syringes are subject to a voluntary recall issued by the manufacturer.
The recalled procedure packs were distributed nationwide in the United States. The recall affects Part Number 58000567, with Lot/Batch Number 6064890. Approximately 211 units were distributed.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000567;
- Manufacturer
- Beaver Visitec International, Inc.
- Affected units
- 211
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: 58000567
- UDI-DI: 30886158019306
- Lot/Batch Number: 6064890
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 159 recalled by Beaver Visitec International, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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