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
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Product | Automated peritoneal dialysis (APD) cycler |
Code Information |
N/A |
Recalling Firm/ Manufacturer |
Baxter Healthcare Corp. 1 Baxter Pkwy Deerfield IL 60015-4625
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = FKX
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