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EXACTAMIX recallZ-1001-2024 · Baxter Healthcare Corporation · initiated Dec 22, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Device Design

What the company is doing

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

Recall details

Recall number
Z-1001-2024
Status
Open, Classified
Initiated by the company
Dec 22, 2023
Posted by the FDA
Feb 16, 2024
Recalling firm
Baxter Healthcare Corporation
Quantity
8 devices
Product code
LHI
FDA submissions
K002705
Distribution
US: AL, AZ, CA, FL, GA, IA, KY, MD, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OR, SD, TX, WA, WI,

Product description

Baxter Exactamix Pro 1200, REF EXM12DY

Code information (models, lots, serial numbers)

UDI/DI 05413765588150, Serial Numbers: PLD2314002, PLD2328001, PLD2328004, PLD2328042, PLD2314006, PLD2328002, PLD2328005, LD2339005

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

7 devices cleared under K002705 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 93700).

Sources and updates

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