Z-3085-2024Class I

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

Name: Z-3085-2024 Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device
Creator: Baxter Healthcare Corporation
Published: 2024-08-20
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2024-08-20 / Open, Classified / root cause: packaging

FDA source

Baxter Healthcare Corporation began a recall of Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device on 2024-08-20. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-3085-2024
Classification: Class I
Status: Open, Classified
Initiated: 2024-08-20
Posted: 2024-09-19
Recalling firm: Baxter Healthcare Corporation
Product: Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device
Product code: LHI Set, I.V. Fluid Transfer
Reason for recall: 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.
Root cause tag: packaging
FDA root cause: Other
Action: 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
Quantity in commerce: 2,140,046 units
Distribution: Worldwide distribution.
Product codes and lots: UDI/DI 00085412475813, Lot Numbers: 803807 and lower

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3085-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3082-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-09-25	2024-09-19
Z-3083-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-09-25	2024-09-19
Z-3084-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-09-25	2024-09-19
Z-3085-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-09-25	2024-09-19

Product code LHI

K002705Class IIExacta-Mix 2400 Compounding System, Model Exacta-Mix 2400Baxa Corp. / cleared 2001-03-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)