Device Recall Phoenix Monitor 의 리콜

Recall

76168

Class 2

Z-1095-2017

2017-01-04

Completed

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152439

Baxter healthcare corporation is issuing a voluntary product recall for several lots of phoenix dialysis machine preventive maintenance kits due to incorrect silicone straight connectors components packaged in these kits. during preventive maintenance, the two silicone connectors must be installed in the phoenix mass-balance section of hydraulic circuit only if the phoenix machine has already been modified with "conn. improving retr. kit" (code sp00721). installation of these connectors in machines modified with sp00721 may result in fluid leaks during dialysis treatment. these preventive maintenance kits include the filter sub-group, which contains the silicone straight connectors that are larger than expected.

Baxter sent an Urgent Product Recall on January 4, 2016, to all affected customers via U.S.P.S., first class mail. Customers were asked to: 1) Locate and remove all affected product lots from their facility. 2) Check if the Preventative Maintenance Kits were already installed in their Phoenix machines and if the case or if uncertain, contact their Baxter Service Representative at 1-800-525-2623 (Option 2) to schedule an appointment to remediate the machine. 3) Contact Baxter Health care Center for Service to arrange for return and credit. 4) Complete the enclosed Baxter Customer Reply Form and return it to Baxter by either fax or scanned email. All non-responding customers will be contacted via telephone. All affected product will be destroyed or discarded. Customers with questions were advised to call 800-437-5176.