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U.S. Department of Health and Human Services

Class 2 Device Recall MiniCap

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 Class 2 Device Recall MiniCapsee related information
Date Initiated by FirmFebruary 25, 2022
Create DateMarch 29, 2022
Recall Status1 Terminated 3 on May 15, 2026
Recall NumberZ-0831-2022
Recall Event ID 89521
Product Classification Set, administration, for peritoneal dialysis, disposable - Product Code KDJ
ProductMiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C4483, R5C4484
Code Information Product Code 5C4482S, UDI: 0085412476261; Lot Number (Expiration Date): H20F02074 (06/02/2025) and H21C31053 (03/31/2026) Product Code R5C4482, UDI: 0085412008776; Lot Number (Expiration Date): H18E18050 (05/18/2023), H20K06084 (11/06/2025), H20L08070 (12/08/2025), H21E07058 (05/07/2026), H21F07049 (06/07/2026), H21F08070 (06/08/2026), H21F28060 (06/28/2026), H21K16066 (11/16/2026) Product Code R5C4483, UDI: 0085412008783; Lot Number (Expiration Date): H18A12037 (01/12/2023) and H20K06035 (11/06/2025) Product Code R5C4484, UDI: 0085412050768; Lot Number (Expiration Date): H17H03057 (08/03/2022), H18G16076 (07/16/2023), H19E31052 (05/31/2024), H21B16056 (02/16/2026)
FEI Number 1417572
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information ContactCenter for One Baxter
847-948-4770
Manufacturer Reason
for Recall		Devices distributed lacked regulatory clearance.
FDA Determined
Cause 2		No Marketing Application
ActionAn Urgent Medical Device Recall communication was sent to affected customers via U.S.P.S., first class mail on 02/25/2022. 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.
Quantity in Commerce498 units
DistributionUS Nationwide distribution in the states of California, Colorado, District of Columbia, Delaware, Florida, Georgia, Illinois, Louisiana, Michigan, Missouri, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, and Texas.
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.
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