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U.S. Department of Health and Human Services

Class 2 Device Recall Automated Peritoneal Dialysis System

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 Class 2 Device Recall Automated Peritoneal Dialysis Systemsee related information
Date Initiated by FirmFebruary 22, 2023
Date PostedApril 01, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1316-2023
Recall Event ID 91776
510(K)NumberK201867 
Product Classification System, peritoneal, automatic delivery - Product Code FKX
ProductAutomated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
Code Information Product Code: 5C6M40; UDI/DI: 0085412676463; Serial Numbers: 2010013403, 2102050403, 2103016303, 2103061703, 2104009103, 2105007803, 2105022503, 2110006603, 2110034803, 2111034103, 2202044303, 2203059903, 2203071803, 2203073003, 2204078503, 2203109603.
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information ContactCenter for One Baxter
800-422-9837
Manufacturer Reason
for Recall		The electrical safety testing was not properly performed on the impacted devices and additional testing is required
FDA Determined
Cause 2		Process design
ActionBaxter notified consignees via phone call on 02/22/2023. The notification outlined the issue and that Baxter was retrieving the units and then replacing them within 24 hours.
Quantity in Commerce16 units
DistributionUS distribution to AL, AR, AZ, FL, IL, ND, NY, OH, TX, WA.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FKX
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