Z-1911-2018 Class II Terminated
FDA device recall Z-1911-2018 was initiated by Baxter Healthcare Corporation on Apr 25, 2018 and is designated Class II. 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 recall status is terminated (terminated Dec 16, 2020). Affected quantity: 112975 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 30, 2018
- Initiation Date
- Apr 25, 2018
- Termination Date
- Dec 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1911-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026