Reported Sep 25, 2013 · Terminated
Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste Management Systems:…
Zeppessis Reprocessing, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zeppessis Reprocessing, LLC · 121 E 38th St Ste 101 · Garden City, ID · 83714-6495
Is this the product you have?
4 of 4 products
| Model / number | Product as published |
|---|---|
700-015-000 | Single-port manifold for the Stryker Neptune 1 ( ) |
700-020-000 | Four-port manifold for the Stryker Neptune 1 ( ) |
702-025-000 | Single-port manifold for the Stryker Neptune 2 ( ) |
702-020-000 | Four-port manifold for the Stryker Neptune 2 ( ). |
- Amount recalled
- undetermined the distributed amounts
Where it was sold
Why it was recalled
Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste Management Systems are recalled due to lacking 510K and and without a validated cleaning protocol for reprocessing the used manifolds.
This product could cause temporary or reversible health problems — stop using it.
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