Baxter EXACTAMIX Inlet Compounders Recalled for Particulate Matter Contamination
Baxter Healthcare is recalling EXACTAMIX Inlet components (H938173 and related codes) due to particulate matter contamination observed in the sterile fluid path before use. Approximately 3.58 million units distributed worldwide are affected.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification per agency determination. Per rubric, FDA Class I recalls never score below 4, as they indicate hazards that could cause serious adverse health consequences.
Plain-English summary
Baxter Healthcare Corporation is recalling disposable inlet components for the ExactaMix and ExactaMix Pro pharmaceutical compounding devices. Affected product codes include H938173, H938174, H938175, and H938176.
Particulate matter has been observed inside the inlet components, including within the sterile fluid path tubing, before use. The company has received increased customer reports of this contamination.
Approximately 3,580,283 units have been distributed worldwide. Affected lot numbers are 803806 and lower, with UDI/DI 00085412475783.
The recalled product
- Product
- Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a pharmaceutical compounding device
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 3,580,283
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 00085412475783
- Lot Numbers: 803806 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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