Recall Z-1570-2022— Baxter Healthcare Corporation

Name: FDA recall Z-1570-2022
Creator: U.S. Food and Drug Administration
Published: 2022-07-14

Class II · Ongoing

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2022-07-14. It names one FDA 510(k) clearance: K002705. Product: The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in the pharmacy to compound multiple source ingredients into one final solution. This device is not intended for direct patient hook-up.. Reason: There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Ongoing
Initiated: 2022-07-14
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K002705 — EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400Baxa Corp.·cleared 2001-03-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in the pharmacy to compound multiple source ingredients into one final solution. This device is not intended for direct patient hook-up.

Reason for recall

There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets.

Data sourced from openFDA. This site is unofficial and independent of the FDA.