- Recalling firm
- Baxter Healthcare Corporation
- 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.
- Affected products (lot / model / serial)
- Lot Code: Lot numbers: 804084, 804088, and 804089 UDI Number: 00085412475806
- Units affected
- 105675
- 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.
- Firm location
- Deerfield, IL, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2262-2026
- Recall initiated
- April 22, 2026
- FDA classification date
- May 29, 2026
- FDA report date
- June 10, 2026
- FDA event ID
- 98852
- Last updated on HTM Vibe
- July 23, 2026