Beaver Visitec Recalls Medical Device Syringes in CustomEyes Procedure Packs
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs because they contain defective syringes manufactured by Sol-M. The 237 affected units were 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 a voluntary FDA Class II medical device recall with no reported injuries or illnesses mentioned in the source text. The voluntary nature and absence of reported harm indicate moderate severity.
Plain-English summary
Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes.
The recalled syringes are identified by Part Number 58000711, UDI-DI 30886158020357, and Lot Number 6073236. A total of 237 units were distributed nationwide.
Patients and healthcare providers who have these procedure packs should discontinue use. Contact Beaver Visitec International for instructions on returns, replacements, or any other questions regarding this recall.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000711;
- 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 (3)
- Part Number: 58000711
- UDI-DI: 30886158020357
- Lot/Batch Number: 6073236
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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