{"url_path":"/fda/device/recalls/Z-2262-2026","section_key":"summary","section_title":"DEVICE Recall: Baxter Healthcare Corporation — 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.","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-04-22","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2262-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Baxter Healthcare Corporation"},"word_count":207,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2262-2026\n\n**Recalling firm:** Baxter Healthcare Corporation\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-22\n**Report date:** 2026-06-10\n\n## Product\nBrand 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.\n\n## Reason\nAffected 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.\n\n## Affected lots\nLot Code: Lot numbers: 804084, 804088, and 804089 UDI Number: 00085412475806\n\n## Distribution\nWorldwide - 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."}