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U.S. Department of Health and Human Services

Class 2 Device Recall MiniCap Extended Life PD Transfer Set

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  Class 2 Device Recall MiniCap Extended Life PD Transfer Set see related information
Date Initiated by Firm November 10, 2020
Create Date January 04, 2021
Recall Status1 Terminated 3 on March 24, 2023
Recall Number Z-0768-2021
Recall Event ID 86883
510(K)Number K192705  
Product Classification Set, administration, for peritoneal dialysis, disposable - Product Code KDJ
Product MiniCap Extended Life PD Transfer Set
Code Information Product Code: 5C4482, UDI: 00085412007731, Lot#, Expiration Date: H20D13100, 4/13/2025; H20D27084, 4/27/2025; H20D30070, 4/30/2025; H20E13107, 5/13/2025; H20E19054, 5/19/2025; H20E22082, 5/22/2025; H20F09061, 6/9/2025; H20F15050, 6/15/2025; H20F18070, 6/18/2025; H20F24086, 6/24/2025; H20F29051, 6/29/2025; H20G13046, 7/13/2025; H20G27087, 7/27/2025; H20G30065, 7/30/2025; H20H05057, 8/5/2025; H20H14067, 8/14/2025; H20H19066, 8/19/2025
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall		 Potential for no-flow and leaks under the twist clamp.
FDA Determined
Cause 2		 Process change control
Action Urgent Medical Device Recall FA-2020-055 was sent to Peritoneal Dialysis Centers via U.S.P.S., first class mail on November 10, 2020. Urgent Medical Device Recall FA-2020-055 was sent via U.S.P.S., first class mail on November 13, 2020 to Home Patients who received impacted lots directly from Baxter. Out of an abundance of caution, Baxter will also be mailing the communication to all home patients who receive treatment at Peritoneal Dialysis Centers which received the impacted lots of transfer sets, regardless if the patient received the set or not.
Quantity in Commerce 72,771 units
Distribution Worldwide and US (Nationwide), Canada, Brazil, Mexico, Bermuda, and Indonesia
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KDJ and Original Applicant = Baxter Healthcare
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