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U.S. Department of Health and Human Services

Class 2 Device Recall Phoenix Monitor

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  Class 2 Device Recall Phoenix Monitor see related information
Date Initiated by Firm January 04, 2017
Create Date January 25, 2017
Recall Status1 Terminated 3 on March 08, 2019
Recall Number Z-1094-2017
Recall Event ID 76168
510(K)Number K103832  
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
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
Code Information Product code: 6997266; Lot codes: 1607250, 160824D, 161005D, 161026D
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer 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.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action 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.
Quantity in Commerce 211 kits
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KDI and Original Applicant = GAMBRO RENAL PRODUCTS, INC.
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