FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device
- Recall number
- Z-3083-2024
- Recalling firm
- Baxter Healthcare Corporation
- Product
- Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device
- Status
- Open, Classified
- Initiated
- 2024-08-20
- Posted
- 2024-09-19
- Terminated
- not on file
- Reason
- 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
- 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
- 1,548,782 units
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- UDI/DI 00085412475790, Lot Numbers: 803799 and lower
- 510(k) numbers
- ["K002705"]
- PMA numbers
- not on file
- Product code
- LHI
- Firm FEI
- 1417572
- Firm city
- Deerfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28