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EXACTAMIX recallZ-3085-2024 · Baxter Healthcare Corporation · initiated Aug 20, 2024

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

Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.

FDA root cause category: Other

What the company is doing

Baxter issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 08/20/2024 via USPS first class mail. The notice explained the issue, hazard involved, and requested the following: "Actions to be Taken by Customers 1. Disseminate this information to anyone who may interact with the ExactaMix and ExactaMix Pro compounders and the products they produce (Pharmacy and Clinical Staff). 2. Pharmacy Staff: Inspect the inlets before use, including the inlet primary packaging, tubing, connectors, and spikes. Perform the inspection in accordance with the enclosed instructions. o If particulate matter is observed, do not use the inlet and contact Baxter Corporate Product Surveillance to report the complaint and to arrange for the safe return of the product for further investigation, see contact information below. Please have your Baxter 8-digit ship-to account number, product code, lot number, and quantity of product to be returned ready when contacting Baxter. The product code and lot number can be found on the individual product pouch and carton. o If no particulate matter is observed, the inlet can be used for compounding. Please ensure the inlet is primed before use according to the instructions provided in the Priming and Verifying section of the ExactaMix and ExactaMix Pro compounder Operator s Manual. 3. Pharmacy and Clinical Staff: After compounding, visually inspect the finished solution in the patient bag for precipitates and particulates per the Fulfilling the Order section in the ExactaMix and ExactaMix Pro compounder Operator s Manual. 4. Use a minimum of 1.2 micron in-line filter during product administration. The American Society for Parenteral and Enteral Nutrition (ASPEN) recommends using a 1.2 microns in-line filter for administration of total nutrient admixtures (TNAs), dextrose-amino acid admixtures, and lipid injectable emulsion. If you are already using in-line filtration per ASPEN recommendation, no additional action is necessary. 5. On

Recall details

Recall number
Z-3085-2024
Status
Open, Classified
Initiated by the company
Aug 20, 2024
Posted by the FDA
Sep 19, 2024
Recalling firm
Baxter Healthcare Corporation
Quantity
2,140,046 units
Product code
LHI
FDA submissions
K002705
Distribution
Worldwide distribution.

Product description

Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device

Code information (models, lots, serial numbers)

UDI/DI 00085412475813, Lot Numbers: 803807 and lower

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

6 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 95192).

Sources and updates

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