Baxter Exactamix Pro 2400, REF EXM24DY
This recall is currently active, issued February 16, 2024. It was issued by Baxter Healthcare Corporation.
- Company
- Baxter Healthcare Corporation
- Recall Initiated
- December 22, 2023
- Posted
- February 16, 2024
- Recall Number
- Z-1002-2024
- Quantity
- 67 devices
- Firm Location
- Deerfield, IL
- Official Source
- View on FDA website ↗
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.
Distribution
US: AL, AZ, CA, FL, GA, IA, KY, MD, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OR, SD, TX, WA, WI,
Lot / Code Info
UDI/DI 05413765588136, Serial Numbers: PLD0019873, PLD2311023, PLD2325014, PLD2339015, PLD0019879, PLD2311029, PLD2325016, PLD2339016, PLD2245007, PLD2311031, PLD2325017, PLD2339017, PLD2303007, PLD2311034, PLD2325018, PLD2339018, PLD2303008, PLD2311036, PLD2325019, PLD2339019, PLD2310013, PLD2325001, PLD2328033, PLD2339020, PLD2310018, PLD2325002, PLD2328034, PLD2339021, PLD2310024, PLD2325003, PLD2328035, PLD2339022, PLD2310025, PLD2325004, PLD2328036, PLD2339023, PLD2310026, PLD2325005, PLD2328037, PLD2339024, PLD2310030, PLD2325006, PLD2328038, PLD2339025, PLD2311001, PLD2325007, PLD2328039, PLD2339026, PLD2311012, PLD2325009, PLD2328043, PLD2339027, PLD2311013, PLD2325010, PLD2339004, PLD2339028, PLD2311014, PLD2325011, PLD2339012, PLD2339029, PLD2311016, PLD2325012, PLD2339013, PLD2342001, PLD2311022, PLD2325013, PLD2339014
Root Cause
Device Design
Action Taken
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 information on alternatives to using overfill, refer to the information on Replacing a Source Container on pages 82-83 in the ExactaMix Pro 2400 Operator Manual and pages 83-84 in the ExactaMix Pro 1200 Operator Manual. 2. If the Use Some Overfill feature is inadvertently used, operators must ensure that: o The Use Some Overfill feature is used only ONCE when an ingredient is depleted. o When prompted to enter the volume of overfill to use, enter LESS THAN the volume left to run stated in the Swap Container window. o On the MixCheck report, verify that all ingredient deliveries that used overfill volume delivered the expected ingredient volume and that the final total volume for the bag aligns with the expected volume. o If you observe redundant ingredient delivery using the overfill volume per the MixCheck report, discard the bag. 3. Always review the final MixCheck report as described in the ExactaMix Pro Operator Manual. Please review the information on this feature on pages 167-171 in the ExactaMix Pro 2400 Operator Manual and pages 164-168 in the ExactaMix Pro 1200 Operator Manual. 4. A Baxter representative will contact your facility when the software upgrade becomes available. Please note you will be receiving this upgrade from Baxter at no charge." If the affected product was distributed to other facilities or departments within your institution, please forward a copy of