Effluent Sample Bag
Recall
- Recall Number
- Z-1144-2022
- Event Number
- 90032
- Firm
- Baxter Healthcare Corporation
- FEI Number
- 1417572
- Product Code
- FKX
- Status
- Open, Classified
- Root Cause
- No Marketing Application
- Initiated
- April 21, 2022
- Address
- 1 Baxter Pkwy, Deerfield, IL, 60015-4625
Description
Effluent Sample Bag
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
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 pre-addressed stamped envelope. The home patient letter was sent on Tuesday, April 26, 2022, via USPS first-class mail.
US Nationwide distribution in the states of CA, MO, MA, AZ, TX, FL, NY, MD, OH.
78 units