device · product 1 of 1
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 number
- Z-2262-2026
- Initiated
- April 22, 2026
- Classification
- Class II
- Status
- Ongoing
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 105675
App-derived interpretation
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.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Inspect official wording and provenance
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.
Code information
Lot Code: Lot numbers: 804084, 804088, and 804089 UDI Number: 00085412475806
Distribution pattern
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.