Baxter EXACTAMIX Inlet recall: Particulate Matter
Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device
Why was Baxter EXACTAMIX Inlet recalled?
Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 00085412475806, Lot Numbers: 803808 and lower
- Product
- Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 5,828,540 units
- Distribution
- Worldwide distribution.
- Recall date
- September 25, 2024
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)