Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H938175 Product Description: Tubing
FDA device recall Z-2262-2026 · posted 2026-05-29 · Open, Classified
Recall details
- 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.
- Action taken
- On April 22, 2026, the firm began notifying consignees via letters titled URGENT PRODUCT RECALL. Customers were instructed to locate impacted product. Customers may choose to inspect impacted inlets and continue to use those with the correct 3-micron filter, or they may choose to discard impacted inlet lots without inspection and product will be replaced.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- NEP
- Quantity affected
- 105675
- Distribution
- Worldwide - US Nationwide distribution including in the states of Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisian
- Date initiated
- 2026-04-22
- Date posted
- 2026-05-29
- Location
- Deerfield, IL
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400 (K002705) | Baxa Corp. | 2001-03-28 |