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 extended expiration dates.
What this means for you
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. The hazard involves labeling errors (blank or extended expiration dates) which are minor labeling issues, fitting the Moderate severity criteria for low-risk contamination or labeling errors without reported serious injury.
Plain-English summary
Baxter Healthcare Corporation is recalling specific lots of EXACTAMIX Inlets, Vented, High-Volume Inlets (REF H938174). These products are disposable components of the Exacta-Mix 2400 Compounding System, used in pharmacies to compound multiple source ingredients into a 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 59,475 units distributed worldwide and in the US. Affected lot numbers are 802279, 802280, and 802281. The UDI for the product is 00085412475790. Users should check their inventory for these specific lot numbers and stop using the affected products.
The recalled product
- Product
- Baxter EXACTAMIX Inlet, Vented, High-Volume Inlet, REF H938174 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
- 59,475
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 (3)
- UDI: 00085412475790 Lot Numbers: 802279
- 802280
- 802281
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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