BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled
Beaver Visitec International recalls BVI CustomEyes Procedure Packs containing Sol-M brand syringes due to manufacturer's voluntary recall. 130 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall. The source text does not describe reported illnesses or injuries, and the specific hazard is not explicitly detailed. Without reported harm and with vague hazard specification, the score is limited to High (3) per rubric criteria for Class II recalls without reported serious outcomes.
Plain-English summary
BVI CustomEyes Procedure Packs containing 1ml Sol-M Luer Lock and Luer Slip syringes (Part Number 58001020, Lot 6068035) are subject to recall by Beaver Visitec International, Inc.
The recall was initiated due to a voluntary recall of these syringes by their manufacturer, Sol-Millennium Medical (Sol-M), Inc. The syringes are components within the BVI CustomEyes Procedure Packs.
Approximately 130 units of the affected procedure packs were distributed nationwide in the United States.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001020;
- Manufacturer
- Beaver Visitec International, Inc.
- Affected units
- 130
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: 58001020
- UDI-DI:30886158022573
- Lot/Batch Number: 6068035
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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