Sol-M Syringes in BVI CustomEyes Procedure Packs Recalled Voluntarily
BVI is recalling CustomEyes Procedure Packs containing syringes from Sol-Millennium Medical due to Sol-M's voluntary recall of those syringes.
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 specified hazard in the source notice. Per the severity rubric, voluntary precautionary recalls without reported harm are classified as Moderate.
Plain-English summary
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical (Sol-M) due to a voluntary recall of those syringes by Sol-M.
The recalled items are CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes (Part Number 58001314, UDI-DI: 30886158023440, Lot Number 6049642). These packs were distributed nationwide in the United States.
The FDA notice does not specify the reason for Sol-M's voluntary recall. Healthcare providers holding these products should contact their supplier for further instructions.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001314;
- Manufacturer
- Beaver Visitec International, Inc.
- Category
- Medical Device — Ophthalmic
- Hazard
- Affected units
- 12
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: 58001314
- UDI-DI: 30886158023440
- Lot/Batch Number: 6049642
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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