BVI CustomEyes Procedure Packs with Sol-M syringes voluntarily recalled
BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes have been voluntarily recalled. The recall affects 124 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: FDA Class II voluntary medical device recall with no documented illnesses or injuries reported in the source. The voluntary precautionary nature indicates a moderate risk level.
Plain-English summary
BVI CustomEyes Procedure Packs containing low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical, Inc. (Sol-M) have been voluntarily recalled. These ophthalmic procedure packs were distributed nationwide, with 124 units affected by this recall.
The affected procedure packs can be identified by Part Number 58000288, Lot Number 6069388, and UDI-DI 30886158013496.
If you have received these procedure packs, stop using them and contact Beaver Visitec International, Inc. for instructions on the recall and replacement options.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000288;
- Manufacturer
- Beaver Visitec International, Inc.
- Hazard
- Affected units
- 124
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: 58000288
- UDI-DI: 30886158013496
- Lot/Batch Number: 6069388
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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