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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 Sharesourcesee related information
Date Initiated by FirmFebruary 16, 2016
Create DateApril 25, 2016
Recall Status1 Terminated 3 on December 23, 2016
Recall NumberZ-1565-2016
Recall Event ID 73435
510(K)NumberK151525 
Product Classification System, peritoneal, automatic delivery - Product Code FKX
ProductAutomated peritoneal dialysis (APD) cycler
Code Information N/A
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp.
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information ContactJacqueline 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
ActionAn 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 Commerce10 units
DistributionUS Consignee: NY ***Foreign Consignee: Ecuador
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FKX
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