Home / Recalls / Baxter Healthcare Corporation / Z-1911-2018

Z-1911-2018 Class II Terminated

Recalled by Baxter Healthcare Corporation — Deerfield, IL

Recall Details

Product Type
Devices
Report Date
May 30, 2018
Initiation Date
April 25, 2018
Termination Date
December 16, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
112975 units

Product Description

Baxter EXACTAMIX Inlet, Syringe Inlet, REF H938176 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,

Distribution Pattern

Worldwide Distribution - US Distribution

Code Information

UDI: 00085412475813 Lot numbers: 802284, 802285, 802286

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