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U.S. Department of Health and Human Services

Class 2 Device Recall Amia Automated PD System with Sharesource

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  Class 2 Device Recall Amia Automated PD System with Sharesource see related information
Date Initiated by Firm February 16, 2016
Create Date April 25, 2016
Recall Status1 Terminated 3 on December 23, 2016
Recall Number Z-1565-2016
Recall Event ID 73435
510(K)Number K151525  
Product Classification System, peritoneal, automatic delivery - Product Code FKX
Product Automated peritoneal dialysis (APD) cycler
Code Information N/A
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp.
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact Jacqueline Kunzler
224-948-2000
Manufacturer Reason
for Recall		 Baxter Healthcare Corporation is sending this communication to inform you of incomplete instructions in the AMIA Automated Peritoneal Dialysis (PO) System Clinician Guide for calculating the total recommended solution therapy volume. Specifically, the instructions do not specify the need for an extra 200 mL of PD solution in order to prime the patient line and for air purge operations. The tot
FDA Determined
Cause 2		 Under Investigation by firm
Action An Urgent Device Correction communication was sent to the one affected customer via U.S.P.S., first class mail on 02/11/2016. A Clinician Guide Addendum was created to instruct clinicians of the extra 200 mL of PD solution required to prime the patient line and for air purge operations. This Addendum was provided as an attachment to the Urgent Device Correction communication letter.
Quantity in Commerce 10 units
Distribution US Consignee: NY ***Foreign Consignee: Ecuador
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 = FKX and Original Applicant = DEKA RESEARCH AND DEVELOPMENT
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