—#152438

Product

Maintenance Kit PH1, Cod. 6997266 The Phoenix Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The Phoenix system is to be used with either high or low permeability dialyzers. The device is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis facility or acute care unit

FDA product code: KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K103832
Affected lot / code info: Product code: 6997266; Lot codes: 1607250, 160824D, 161005D, 161026D

Why it was recalled

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.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2017-01-04
Terminated: 2019-03-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #152438. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.