Baxter pharmaceutical compounding inlets recalled for particulate matter contamination
Baxter is recalling EXACTAMIX compounding device inlets due to particulate matter observed in sterile fluid pathways before use. Approximately 5.8 million units affected worldwide.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I classification indicates reasonable probability of serious adverse health consequences. Particulate matter in the sterile fluid path of pharmaceutical compounding inlets presents direct risk to medication preparation and patient safety.
Plain-English summary
Baxter Healthcare Corporation is recalling EXACTAMIX and ExactaMix Pro compounding device inlets due to the presence of particulate matter in the product. The inlets are disposable components used in pharmaceutical compounding devices, specifically product codes H938173, H938174, H938175, and H938176.
Particulate matter has been discovered within the inlet primary packaging and sterile fluid path tubing, before customer use. This contamination could compromise the sterility and integrity of pharmaceutically compounded medications, presenting a risk to patient safety.
The recall affects approximately 5.8 million units with lot numbers 803808 and lower, distributed worldwide. Customers and healthcare facilities currently using these inlets should stop use immediately and contact Baxter Healthcare for replacement units or further instructions.
The recalled product
- Product
- Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 5,828,540
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 00085412475806
- Lot Numbers: 803808 and lower
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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