BEUDAMED
    FDA Recall Open, Classified

    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.

    Recall: Z-2262-2026 · Initiated April 22, 2026

    Recall

    Recall Number
    Z-2262-2026
    Event Number
    98852
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    NEP
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 22, 2026
    Posted
    May 29, 2026
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    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.

    Reason

    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.

    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.

    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.

    Quantity

    105675