Z-0485-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 7, 2018
- Initiation Date
- July 27, 2017
- Termination Date
- November 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.