Recall Z-3133-2017
Baxter Healthcare Corp · initiated September 1, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479
Codes / lots: 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
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: Equipment maintenance
Action taken
The 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.
Details
- Recall number
- Z-3133-2017
- Initiated
- September 1, 2017
- Terminated
- August 27, 2019
- Product code
- FKX – System, Peritoneal, Automatic Delivery
- Quantity
- 164,700 units
- Distribution
- nationwide, Canada
- Recalling firm
- Baxter Healthcare Corp, Mountain Home, AR