FDAClass IIApril 6, 2022

MiniCap Extended Life PD Transfer Set recall

MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C4483, R5C4484

Why was MiniCap Extended Life PD Transfer Set recalled?

Devices distributed lacked regulatory clearance.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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)

Product
MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C4483, R5C4484
Recalling firm
Baxter Healthcare Corporation
Quantity
498 units
Distribution
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.
Recall date
April 6, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls