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U.S. Department of Health and Human Services

Class 1 Device Recall Baxter EXACTAMIX

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 Class 1 Device Recall Baxter EXACTAMIXsee related information
Date Initiated by FirmAugust 20, 2024
Date PostedSeptember 19, 2024
Recall Status1 Open3, Classified
Recall NumberZ-3084-2024
Recall Event ID 95192
510(K)NumberK002705 
Product Classification Set, i.V. Fluid transfer - Product Code LHI
ProductBaxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device
Code Information UDI/DI 00085412475806, Lot Numbers: 803808 and lower
Recalling Firm/
Manufacturer
Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information ContactCenter for One Baxter
800-422-9837
Manufacturer 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.
FDA Determined
Cause 2
Other
ActionBaxter 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 Commerce5,828,540 units
DistributionWorldwide distribution.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LHI
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