Z-2262-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 10, 2026
- Initiation Date
- April 22, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 105675
Product 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 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.
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.
Code Information
Lot Code: Lot numbers: 804084, 804088, and 804089 UDI Number: 00085412475806