Baxter EXACTAMIX pharmaceutical compounding inlets recalled for particulate contamination
Baxter Healthcare Corporation is recalling EXACTAMIX Inlet components due to particulate matter found in sterile fluid path tubing. Approximately 1.5 million units were distributed worldwide.
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 classification indicates a serious hazard requiring manufacturer recall action. Particulate contamination in pharmaceutical compounding device inlets could compromise medication sterility and safety, though no illnesses or injuries have been reported to date.
Plain-English summary
Baxter Healthcare Corporation has recalled EXACTAMIX Inlet components (product codes H938173, H938174, H938175, H938176) used with ExactaMix and ExactaMix Pro pharmaceutical compounding devices. The recall was initiated after Baxter received increased customer reports of particulate matter observed within inlet components, including within the sterile fluid path tubing, before use.
Approximately 1,548,782 units were distributed worldwide under UDI/DI 00085412475790, with affected lot numbers 803799 and lower. These are disposable inlets used in pharmaceutical compounding.
Particulate contamination in components used for pharmaceutical compounding could compromise medication sterility. Healthcare facilities and pharmacies should verify whether they have devices with the affected product codes and lot numbers.
The recalled product
- Product
- Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 1,548,782
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 00085412475790
- Lot Numbers: 803799 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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