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U.S. Department of Health and Human Services

Class 2 Device Recall APD Drain Manifold

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  Class 2 Device Recall APD Drain Manifold see related information
Date Initiated by Firm April 21, 2022
Create Date May 27, 2022
Recall Status1 Open3, Classified
Recall Number Z-1146-2022
Recall Event ID 90032
Product Classification Set, administration, for peritoneal dialysis, disposable - Product Code KDJ
Product APD Drain Manifold
Code Information Product code: R5C4512; UDI: 00085412008790; Lot Number: H18D03030 (exp. date: 04/03/2023), Lot Number: H18E31046 (exp. date: 05/31/2023), Lot Number: H18L04065 (exp. date:12/04/2023), Lot Number: H20H10073 (exp. date: 08/10/2022)
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact Center for One Baxter
847-948-4770
Manufacturer Reason
for Recall		 Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
FDA Determined
Cause 2		 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 pre-addressed stamped envelope. The home patient letter was sent on Tuesday, April 26, 2022, via USPS first-class mail.
Quantity in Commerce 180 units
Distribution US Nationwide distribution in the states of CA, MO, MA, AZ, TX, FL, NY, MD, OH.
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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