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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter Amia Automated Peritoneal Dialysis Set with Cassette

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 Class 2 Device Recall Baxter Amia Automated Peritoneal Dialysis Set with Cassettesee related information
Date Initiated by FirmSeptember 01, 2017
Create DateSeptember 14, 2017
Recall Status1 Terminated 3 on August 27, 2019
Recall NumberZ-3133-2017
Recall Event ID 78085
510(K)NumberK151525 
Product Classification System, peritoneal, automatic delivery - Product Code FKX
ProductBaxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479
Code Information Lot numbers: H16G28107, H16H01086, H16H04114, H16H09063, H16H13032, H16H19112, H16H26034, H16H30010, H16I02017, H16I06018, H16I08071, H16I12016, H16I14103, H16I16066, H16I19060, H16I21058, H16I23047, H16I26065, H16I30091, H16J03014, H16J05035, H16J07015, H16J09078, H16J11132, H16J14011, H16J16057, H16J18046, H16J20109, H16J22063, H16J24127, H16J26072, H16J28128, H16J30058, H16K01057, H16K03079, H16K05041, H16K07054, H16K08086, H16K10090, H16K28027, H16K30015, H16L04034, H16L11039, H16L15105
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp
1900 Highway 201 N
Mountain Home AR 72653-2433
For Additional Information ContactCenter for One Balxter
800-422-9837
Manufacturer Reason
for Recall		The firm received increased customer complaints for Missing Red Line, Patient Slow Flow, Solution Slow Flow, and Inadequate Drain alerts on certain lots of the AMIA Automated Peritoneal Dialysis Set with Cassette.
FDA Determined
Cause 2		Equipment maintenance
ActionThe firm initiated the recall by letter on 09/05/2017. The patients and clinics were directed to locate and remove all affected product and to contact Baxter Healthcare Center for Service to arrange for return and credit. The Baxter Healthcare Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday.
Quantity in Commerce164,700 units
Distributionnationwide, Canada
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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