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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter Renal Software Suite for Windows

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  Class 2 Device Recall Baxter Renal Software Suite for Windows see related information
Date Initiated by Firm April 12, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on February 26, 2008
Recall Number Z-0901-04
Recall Event ID 28762
510(K)Number K990953  
Product Classification unknown device name - Product Code KPF--
Product Baxter Renal Software Suite (Renal Link and PD Link); Baxter Healthcare Corporation, McGaw Park, Illinois 60085
Code Information product codes 5M5590, 5M5591, 5M5592, 5M5593, 5M5594, 5M5595, 5M5596, 5M5603, 5M5604, R5C4532, R5C4534, 5M5597, 5M5541, 5M5541R, all software versions
Recalling Firm/
Manufacturer
Baxter Healthcare Renal Div
1620 Waukegan Rd Bldg R
Mc Gaw Park IL 60085-6730
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall
There are software anomalies present that may increase the possibility of a medication error if the dialysis clinic software is used to track, record, or coordinate the administration of medications.
FDA Determined
Cause 2
Other
Action Baxter sent Urgent Device Correction letters dated 4/12/04 to the attention of the Dialysis Unit Administrator. Separate letters were sent to the Renalsoft customers and to the Renal Software Suite customers. The letters described the software anomalies associated with the software and provided interim workaround instructions until permanent corrective actions to these anomalies can be identified.
Quantity in Commerce 4,148 units
Distribution Nationwide

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 = KPF-- and Original Applicant = BAXTER HEALTHCARE CORP.
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