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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 Setsee related information
Date Initiated by FirmNovember 10, 2020
Create DateJanuary 04, 2021
Recall Status1 Terminated 3 on March 24, 2023
Recall NumberZ-0768-2021
Recall Event ID 86883
510(K)NumberK192705 
Product Classification Set, administration, for peritoneal dialysis, disposable - Product Code KDJ
ProductMiniCap 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 ContactCenter 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
ActionUrgent 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 Commerce72,771 units
DistributionWorldwide and US (Nationwide), Canada, Brazil, Mexico, Bermuda, and Indonesia
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KDJ
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