Recall Z-1001-2024— Baxter Healthcare Corporation

Name: FDA recall Z-1001-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-22

Class I · Ongoing

Class I FDA medical device recall by Baxter Healthcare Corporation, initiated 2023-12-22. It names one FDA 510(k) clearance: K002705. Product: Baxter Exactamix Pro 1200, REF EXM12DY. Reason: An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature which may lead to over-delivery of an ingredient. This issue can result in redundant ingredient delivery of the requested overfill volume..

Recalling firm: Baxter Healthcare Corporation
Classification: Class I
Status: Ongoing
Initiated: 2023-12-22
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

Baxter Exactamix Pro 1200, REF EXM12DY

Reason for recall

An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature which may lead to over-delivery of an ingredient. This issue can result in redundant ingredient delivery of the requested overfill volume.

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