Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1911-2018·Announced 2018-05-30

Baxter EXACTAMIX Inlets Recalled for Incorrect 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. The hazard involves labeling errors (blank or extended expiration dates) which are considered minor labeling errors or low-risk contamination issues under the rubric, as no specific injuries or illnesses are reported in the source text.

Plain-English summary

Baxter Healthcare Corporation is recalling specific lots of EXACTAMIX Inlets, Syringe Inlet, REF H938176. These products are disposable components of the Exacta-Mix 2400 Compounding System, which is used in pharmacies to compound multiple source ingredients into one final solution.

The recall was initiated because the inlets were incorrectly over-labeled. Some units were labeled with a blank label, while others were labeled with 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 112,975 units distributed worldwide and in the US. Affected lot numbers are 802284, 802285, and 802286. The UDI for the product is 00085412475813. Users should check their inventory for these specific lot numbers and stop using the affected products.

The recalled product

Product: Baxter EXACTAMIX Inlet, Syringe Inlet, REF H938176 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
Category: Medical Device — Pharmacy Compounding Components
Hazard: mis-labeling
expiration-date-error
Affected units: 112,975

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: 00085412475813 Lot numbers: 802284
802285
802286

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.

See all 4 products in this recall →

Same manufacturer · Baxter Healthcare Corporation

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