BVI CustomEyes Procedure Packs recalled due to Sol-M syringes
BVI CustomEyes Procedure Packs containing Sol-M syringes are being recalled due to a voluntary manufacturer recall of the syringe components included in these procedure packs.
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 precautionary recall initiated by the syringe manufacturer with no reported illnesses or injuries mentioned in the source. While classified as FDA Class II, the absence of reported incidents and the manufacturer-initiated precautionary action result in a Moderate severity score.
Plain-English summary
BVI CustomEyes Procedure Packs have been recalled due to a voluntary manufacturer recall of syringes made by Sol-Millennium Medical (Sol-M), Inc. The affected packs contain Sol-M low dead space syringes and luer slip tip syringes, identified by part number 58001568.
Approximately 45 units of the affected procedure packs were distributed to medical facilities and suppliers throughout the United States. The recalled syringe lot numbers are 6059666 and 6073550. This recall was initiated voluntarily by the syringe manufacturer as a precautionary measure.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001568;
- Manufacturer
- Beaver Visitec International, Inc.
- Category
- Medical Device — Syringes
- Hazard
- Affected units
- 45
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 (4)
- Part Number: 58001568
- UDI-DI: 30886158024683
- Lot/Batch Number: 6059666
- 6073550
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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