PhaseOne antimicrobial solution sprayer springs may corrode into the product
PhaseOne Antimicrobial Solution is being recalled because the stainless steel spring inside the sprayer can corrode, releasing trace metallic elements into the solution.
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 recall where corrosion can introduce metallic elements into a solution applied to patients, a risk of harm with no injuries reported.
Plain-English summary
PhaseOne Antimicrobial Solution, model/catalog number 15050, UDI 00860009268616, lot 25G263, is being recalled. The action covers 5,904 units.
The recall is due to corrosion of the internal metallic spring within the sprayer component. According to the manufacturer, the 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 FDA classified the action as Class II.
Distribution was within the United States, including Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kentucky and Michigan. The product is supplied to healthcare settings.
Facilities should identify affected stock using the catalog number, UDI and lot number above, quarantine it, and follow the instructions issued by the manufacturer.
The recalled product
- Product
- PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050
- Manufacturer
- Oculus Technologies of Mexico, S.A. de C.V.
- Affected units
- 5,904
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
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