Baxter EXACTAMIX Inlets Recalled for Incorrect Over-Labeling
Baxter Healthcare is recalling specific lots of EXACTAMIX Inlets due to incorrect over-labeling that may display blank or extended expiration dates.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is limited to labeling errors (blank or extended expiration dates) without reported injuries or illnesses, fitting the criteria for moderate severity involving minor labeling errors or low-risk contamination.
Plain-English summary
Baxter Healthcare Corporation is recalling specific lots of EXACTAMIX Inlets, Vented, Micro-Volume Inlets (REF H938175). These products are disposable components of the Exacta-Mix 2400 Compounding System, used in pharmacies to compound multiple source ingredients into one final solution.
The recall is due to incorrectly performed over-labeling. The affected inlets were over-labeled with a blank label or with a label containing an extended expiration date. The source text notes that if the product is used beyond the expiration date, potential risks may arise, though specific adverse events are not detailed in the provided text.
The recall involves 75,350 units with Lot Numbers 802282 and 802283. The products were distributed worldwide and in the US. Users should check their inventory for these specific lot numbers and stop using the affected products.
The recalled product
- Product
- Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 75,350
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: 00085412475806 Lot Numbers: 802282
- 802283
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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