Baxter Exacta Mix inlet sets may contain incorrect 0.8-micron filters
Exacta Mix Vented Micro-Volume Inlet tubing sets are being recalled because affected lots may contain 0.8-micron filters in place of the validated 3-micron filters.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall where a wrong-specification filter may disrupt compounded ingredient transfers, a risk of harm with no injuries reported in the source.
Plain-English summary
The Exacta Mix Vented Micro-Volume Inlet, catalog number H938175, from Baxter Healthcare Corporation, is being recalled. The product is a tubing set with a push-on connector on one end to attach to the fluid selector valve and a spike or other appropriate fitting on the other. The action covers 105,675 units.
Affected lots may contain incorrect 0.8-micron filters. According to the manufacturer, 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, and this issue may lead to clinical effects such as electrolyte imbalance, metabolic instability and delayed recovery. The FDA classified the action as Class II.
Affected lots are 804084, 804088 and 804089, UDI 00085412475806. Distribution was worldwide, including nationwide in the United States. The sets are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the catalog number, lot numbers and UDI above, quarantine it, and follow the instructions issued by Baxter.
The recalled product
- 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…
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 105,675
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot Code: Lot numbers: 804084
- 804088
- and 804089 UDI Number: 00085412475806
Distribution
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