BVI CustomEyes Procedure Packs containing syringes recalled nationwide
BVI CustomEyes Procedure Packs containing Sol-M syringes are subject to a voluntary recall affecting 73 units 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: The source indicates a voluntary, precautionary recall of medical device syringes without reported illnesses or injuries. FDA Class II classification applies, but without documented harm or clear hazard description, this meets the rubric criteria for a moderate-severity, precautionary recall.
Plain-English summary
BVI CustomEyes Procedure Packs containing low dead space and Luer slip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. are being voluntarily recalled. The affected product has Part Number 584712 and Lot/Batch Number 6070547.
Approximately 73 units of the affected procedure packs were distributed across the United States.
The recalled product can be identified by UDI-DI 30886158142455.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584712;
- Manufacturer
- Beaver Visitec International, Inc.
- Hazard
- Affected units
- 73
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: 584712
- UDI-DI: 30886158142455
- Lot/Batch Number: 6070547
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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