[pending] PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050
Pending LLM rewrite. Source: FDA_DEVICE Z-2275-2026.
What this means for you
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: Pending LLM scoring against the rubric.
Plain-English summary
The recall is being conducted due to corrosion of the internal metallic spring within the sprayer component. This condition is caused by material incompatibility between the product solution and the stainless steel spring and may result in visible discoloration and the presence of trace levels of metallic elements (including iron, chromium, and nickel) in the solution during use.
The recalled product
- Product
- PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050
- Manufacturer
- Oculus Technologies of Mexico, S.A. de C.V.
- Category
- Medical Device — Devices
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)
- UDI:00860009268616 Lot: 25G263
Distribution
Distributed nationwide across the United States.
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