Home / Recalls / Baxter Healthcare Corporation / Z-0831-2022

Z-0831-2022 Class II Terminated

Recalled by Baxter Healthcare Corporation — Deerfield, IL

Recall Details

Product Type
Devices
Report Date
April 6, 2022
Initiation Date
February 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)

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