Z-2262-2026Class II

Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H938175 Product...

Name: Z-2262-2026 Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H938175 Product...
Creator: Baxter Healthcare Corporation
Published: 2026-04-22
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2026-04-22 / Open, Classified

FDA source

Baxter Healthcare Corporation began a recall of Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H938175 Product Description: Tubing sets with push-on connector on one end... on 2026-04-22. FDA classified it as Class II and gives the reason as "Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of the validated 3-micron filter may lead to reduced flow efficiency, incomplete or slower transfers of ingredients, or system...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2262-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-22
Posted: 2026-05-29
Recalling firm: Baxter Healthcare Corporation
Product: Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H938175 Product Description: Tubing sets with push-on connector on one end (to attach to the Fluid Selector Valve) and a spike or other appropriate connector on the opposite end to attach the source container.
Product code: NEP System/Device, Pharmacy Compounding
Reason for recall: Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of the validated 3-micron filter may lead to reduced flow efficiency, incomplete or slower transfers of ingredients, or system alarms. This issue may lead to clinical effects such as electrolyte imbalance, metabolic instability, delayed recovery, etc.
FDA root cause: Under Investigation by firm
Action: On April 22, 2026, the firm began notifying consignees via letters titled URGENT PRODUCT RECALL. Customers were instructed to locate impacted product. Customers may choose to inspect impacted inlets and continue to use those with the correct 3-micron filter, or they may choose to discard impacted inlet lots without inspection and product will be replaced.
Quantity in commerce: 105675
Distribution: Worldwide - US Nationwide distribution including in the states of Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia. The countries of Taiwan and Uruguay.
Product codes and lots: Lot Code: Lot numbers: 804084, 804088, and 804089 UDI Number: 00085412475806

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2262-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2262-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-05-29

Product code NEP

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)