Recall Z-1094-2017— Baxter Healthcare Corporation

Name: FDA recall Z-1094-2017
Creator: U.S. Food and Drug Administration
Published: 2017-01-04

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2017-01-04, terminated 2019-03-08. It names one FDA 510(k) clearance: K103832. 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. Reason: 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..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-01-04
Terminated: 2019-03-08
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K103832 — PHOENIX HEMODIALYSIS DELIVERY SYSTEMGambro Renal Products, Inc.·cleared 2011-05-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.