3,65 m Extension Set with Luer-lock Connector
- Company
- Baxter Healthcare Corporation
- Recall Initiated
- April 21, 2022
- Recall Number
- Z-1145-2022
- Quantity
- 60 units
- Firm Location
- Deerfield, IL
Reason for Recall
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
Distribution
US Nationwide distribution in the states of CA, MO, MA, AZ, TX, FL, NY, MD, OH.
Lot / Code Info
Product code: R5C4480F; UDI: 00085412577142; Lot Number: H19G12025 (exp. date: 07/12/2024)
Root Cause
No Marketing Application
Action Taken
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.