Recall Z-2212-2013 ยท JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Zeppessis Reprocessing, LLC
Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste Management Systems: The Neptune Waste management system is intended to be used in the Operating Room, Surgical Centers and Doctor's Offices to collect and dispose of surgical fluid waste as well as collect smoke generated from electrocautory or laser devices. ***The single-port manifold for the Str
| Date | Sep 17, 2013 (initiated Aug 16, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Reprocessing Controls |
| Action | Zeppessis Reprocessing, LLC sent an Urgent Medical Device Recall letter dated September 4, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are advised to stop using the Zeppessis reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste Management Systems immediately and instructed to destroy the products in a proper manner. Customers should fill out the Customer Response form and fax or email it back to Zeppessis. For any questions about this recall, please call Ze |
| Quantity | undetermined the distributed amounts |
| Distribution | Distributed in the states of California, Idaho, Oregon, and Washington. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.