PlainRecalls
FDA Devices Moderate Class II Terminated

Baxter EXACTAMIX Inlet, Vented, High-Volume Inlet, REF H938174 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.

Reported: May 30, 2018 Initiated: April 25, 2018 #Z-1909-2018

Product Description

Baxter EXACTAMIX Inlet, Vented, High-Volume Inlet, REF H938174 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.

Reason for Recall

Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the expiration date,

Details

Units Affected
59475 units
Distribution
Worldwide Distribution - US Distribution
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
Baxter EXACTAMIX Inlet, Vented, High-Volume Inlet, REF H938174 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.. Recalled by Baxter Healthcare Corporation. Units affected: 59475 units.
Why was this product recalled?
Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the expiration date,
Which agency issued this recall?
This recall was issued by the FDA Devices on May 30, 2018. Severity: Moderate. Recall number: Z-1909-2018.