Zeppessis' reprocessed single-use manifolds recall
Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste Management Systems: The Neptune Waste management…
Why was Zeppessis' reprocessed single-use manifolds 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
-Single-port manifold for the Stryker Neptune 1 (part # 700-015-000); -Four-port manifold for the Stryker Neptune 1 (part # 700-020-000); -Single-port manifold for the Stryker Neptune 2 (part # 702-025-000); -Four-port manifold for the Stryker Neptune 2 (part # 702-020-000).
- Product
- Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste Management Systems: The Neptune Waste management…
- Recalling firm
- Zeppessis Reprocessing, LLC
- Quantity
- undetermined the distributed amounts
- Distribution
- Distributed in the states of California, Idaho, Oregon, and Washington.
- Recall date
- September 25, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)