Baxter Healthcare Corporation: System/device, Pharmacy Compounding
Consumer Summary Baxter Healthcare is recalling Exacta Mix Vented Micro-Volume Inlet tubing sets used in pharmacy compounding systems because some units contain incorrect 0.8-micron filters instead of the proper 3-micron filters. The wrong filter can slow or block the transfer of ingredients and trigger system alarms, potentially causing incomplete medication preparation and patient complications like electrolyte imbalance or delayed recovery. The affected products were distributed nationwide across the U.S., as well as in Taiwan and Uruguay.
- 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.
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-22
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/6e2a01b8-c1e8-49ee-9fe4-be60988b54a9