Z-0485-2018 Class II Terminated
FDA device recall Z-0485-2018 was initiated by Baxter Healthcare Corporation on Jul 27, 2017 and is designated Class II. Reason for recall: A leak may allow for microbial contamination of the sterile fluid path. The recall status is terminated (terminated Nov 3, 2020). Affected quantity: 29,088 units.
Recall details
- Product Type
- Devices
- Report Date
- Feb 7, 2018
- Initiation Date
- Jul 27, 2017
- Termination Date
- Nov 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29,088 units
Product description
Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.
Reason for recall
A leak may allow for microbial contamination of the sterile fluid path.
Distribution pattern
Distribution in the US and Canada.
Code information
Product Code 2J8003, Lot No. DR16J18096.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0485-2018
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026