Recall Z-1144-2022 ยท FKX System, Peritoneal, Automatic Delivery
Baxter Healthcare Corporation
Effluent Sample Bag
| Date | Apr 21, 2022 |
| Status | Terminated |
| Reason | Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error. |
| Root cause | No Marketing Application |
| Action | An Urgent Medical Device Recall communication was sent to affected peritoneal dialysis centers via U.S.P.S., first class mail on 04/21/2022. Instructions within the communication request customers to locate and return any unused affected product codes and lots from their facility, contact Baxter Healthcare Center for Service to arrange for return and credit at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday, and acknowledge the receipt of this notification by completing a reply form on the customer portal or by returning a reply form in the enclosed pr |
| Quantity | 78 units |
| Distribution | US Nationwide distribution in the states of CA, MO, MA, AZ, TX, FL, NY, MD, OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.