BVI CustomEyes Procedure Packs Recalled Due to Syringe Defect
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M syringes. The voluntary recall affects 237 units distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 an FDA Class II voluntary precautionary recall with no reported illnesses or injuries. The rubric designates voluntary recalls without reported harm as Moderate severity.
Plain-English summary
Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs (Part Number 58000813) that contain syringes manufactured by Sol-Millennium Medical, Inc. The affected units contain low dead space Luer Lock and Luer Slip 1ml syringes. This is a voluntary recall.
The affected lot numbers are 6068010 and 6075202. A total of 237 units have been distributed nationwide in the United States.
Healthcare providers or facilities that have received these procedure packs should contact Beaver Visitec International for instructions on how to proceed.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000813;
- Manufacturer
- Beaver Visitec International, Inc.
- Hazard
- Affected units
- 237
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: 58000813
- UDI-DI: 30886158020524
- Lot/Batch Number: 6068010
- 6075202
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.
See all 159 products in this recall →Related recalls
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