Malosa Core Phaco Pack 2 Surgical Kit Recalled for Packaging Sterility Risk
Beaver Visitec International is recalling the Malosa Core Phaco Pack 2 medical refractive kit due to small holes in the kit packaging that may compromise product sterility.
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 recall with no reported illnesses or injuries. The hazard is a low-risk packaging defect that may compromise sterility, classified as a precautionary recall. Without evidence of actual harm and with only a theoretical contamination risk, the severity is Moderate.
Plain-English summary
Beaver Visitec International, Inc. is recalling the Malosa Core Phaco Pack 2 Medical Refractive Kit (Part Number MMK834/1), a surgical device intended to aid in cataract, corneal, and refractive surgery. The recall has been issued because the kit packaging may have small holes that could compromise the product's sterility.
Thirty units of the affected product were distributed to locations in California, Colorado, Louisiana, Massachusetts, Maryland, North Dakota, Pennsylvania, Tennessee, and Utah. The affected lot number is 3289074.
No illnesses or injuries have been reported in connection with this recall. Healthcare facilities and practitioners who have received this product should contact the manufacturer for instructions on product replacement or return.
The recalled product
- Product
- Malosa Core Phaco Pack 2- Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK834/1
- Manufacturer
- Beaver Visitec International, Inc.
- Affected units
- 30
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 (1)
- Lot Numbers: 3289074
Distribution
Part of a larger recall action
This product is one of 6 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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