BVI Recalls CustomEyes Procedure Packs Containing Recalled Sol-M Syringes
BVI is recalling CustomEyes Procedure Packs because they contain syringes subject to a separate voluntary recall by manufacturer Sol-Millennium Medical. The recall affects 217 units 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 a voluntary Class II medical device recall without reported illnesses or injuries, and without specification of a particular hazard in the source material. It qualifies as a precautionary recall consistent with a Moderate severity classification.
Plain-English summary
Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs that contain Sol-Millennium Medical (Sol-M) brand syringes. The product is subject to a voluntary recall initiated due to the underlying syringes, which are part of the procedure packs distributed nationwide.
The recalled procedure packs contain Sol-M Luer Lock and Luer Slip 1ml syringes (Part Number 58000455, UDI-DI: 30886158018644, Lot/Batch Number: 6062130). A total of 217 units have been distributed throughout the United States.
Customers who have received affected procedure packs should contact the manufacturer for further information and instructions regarding the recall.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000455;
- Manufacturer
- Beaver Visitec International, Inc.
- Hazard
- Affected units
- 217
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: 58000455
- UDI-DI: 30886158018644
- Lot/Batch Number: 6062130
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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