Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a pharmaceutical compounding device
This recall is currently active, issued September 19, 2024. It was issued by Baxter Healthcare Corporation.
- Company
- Baxter Healthcare Corporation
- Recall Initiated
- August 20, 2024
- Posted
- September 19, 2024
- Recall Number
- Z-3082-2024
- Quantity
- 3,580,283 units
- Firm Location
- Deerfield, IL
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide distribution.
Lot / Code Info
UDI/DI 00085412475783, Lot Numbers: 803806 and lower
Root Cause
Other
Action Taken
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