Baxter ExactaMix Inlets Recalled for Particulate Contamination Risk
Baxter Healthcare is recalling ExactaMix pharmaceutical compounding device inlets due to increased reports of particulate matter in the sterile fluid path before use. The recall involves 2,140,046 units with worldwide distribution.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall. Per the rubric, FDA Class I medical device recalls have a minimum severity score of 4 (Severe), regardless of whether illnesses have been reported.
Plain-English summary
Baxter Healthcare Corporation is recalling the EXACTAMIX Inlet, Vented, Syringe Inlet (REF H938176 and related product codes), used in ExactaMix and ExactaMix Pro pharmaceutical compounding devices. Lot Numbers 803807 and lower are included in this recall.
The company has received increased customer reports of particulate matter found within the inlet components, specifically in the sterile fluid path tubing, observed before use. The inlets are disposable components designed for use in pharmaceutical compounding applications.
Approximately 2,140,046 units have been distributed worldwide. Healthcare facilities and pharmacies using these compounding devices should verify whether their inlets are from the affected lot numbers (803807 and lower, UDI/DI 00085412475813).
Healthcare providers should contact Baxter Healthcare Corporation immediately for instructions on handling affected inlets and potential replacement options. Users should not use affected inlets in compounding operations.
The recalled product
- Product
- Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 2,140,046
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 (2)
- UDI/DI 00085412475813
- Lot Numbers: 803807 and lower
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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