Recall Z-1001-2024 ยท LHI Set, I.V. Fluid Transfer
Baxter Healthcare Corporation
Baxter Exactamix Pro 1200, REF EXM12DY
| Date | Feb 16, 2024 (initiated Dec 22, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | Baxter issued an Urgent Medical Device Correction notice to its consignees on 12/22/2023 via USPS First Class mail. The notice explained the issue with the device, potential risks, and requested the following actions be taken for the safe operation until a software upgrade is released: "1. Operators may continue to use the ExactaMix Pro compounders, but when the system prompts the operator that ingredients are depleted, operators should choose to Swap Container or Use a Different Container and not utilize the Use Some Overfill feature until further notice by Baxter. For more informati |
| Quantity | 8 devices |
| Distribution | US: AL, AZ, CA, FL, GA, IA, KY, MD, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OR, SD, TX, WA, WI, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002705 | EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400 Baxa Corp., Mar 28, 2001 |