Z-1908-2018Class II

Baxter EXACTAMIX Inlet, Non-Vented, High-Volume Inlet, REF H938173

Name: Z-1908-2018 Baxter EXACTAMIX Inlet, Non-Vented, High-Volume Inlet, REF H938173
Creator: Baxter Healthcare Corporation
Published: 2018-04-25
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2018-04-25 / Terminated / root cause: labeling and UDI

FDA source

Baxter Healthcare Corporation began a recall of Baxter EXACTAMIX Inlet, Non-Vented, High-Volume Inlet, REF H938173 Product Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable... on 2018-04-25. FDA classified it as Class II and gives the reason as "Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1908-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-25
Posted: 2018-05-22
Terminated: 2020-12-16
Recalling firm: Baxter Healthcare Corporation
Product: Baxter EXACTAMIX Inlet, Non-Vented, High-Volume Inlet, REF H938173 Product 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.
Product code: LHI Set, I.V. Fluid Transfer
Reason for recall: Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the expiration date,
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: The firm initiated the recall by letter on 04/25/2018. The letter identified the affected product, problem and actions to be taken. the firm requested the return of the product. Distributors were directed to conduct a sub-recall, requesting their customers return the product to the entity from whom they received the product.
Quantity in commerce: 98700 units
Distribution: Worldwide Distribution - US Distribution
Product codes and lots: UDI: 00085412475783 Lot Numbers: 802277, 802278, 802383, 802384, 802385

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1908-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1908-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-30	2018-05-22
Z-1909-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-30	2018-05-22
Z-1910-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-30	2018-05-22
Z-1911-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-30	2018-05-22

Product code LHI

K002705Class IIExacta-Mix 2400 Compounding System, Model Exacta-Mix 2400Baxa Corp. / cleared 2001-03-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)