Z-0831-2022 Class II Terminated
FDA device recall Z-0831-2022 was initiated by Baxter Healthcare Corporation on Feb 25, 2022 and is designated Class II. Reason for recall: Devices distributed lacked regulatory clearance. The recall status is terminated (terminated May 15, 2026). Affected quantity: 498 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 6, 2022
- Initiation Date
- Feb 25, 2022
- Termination Date
- May 15, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 498 units
Product Description
MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C4483, R5C4484
Reason for Recall
Devices distributed lacked regulatory clearance.
Distribution Pattern
US 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.
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)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0831-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026