Z-0003-2020 Class II Ongoing
FDA device recall Z-0003-2020 was initiated by The Metrix Company on Sep 21, 2018 and is designated Class II. Reason for recall: Potential for leaking product The recall status is ongoing. Affected quantity: 1512 bags.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 9, 2019
- Initiation Date
- Sep 21, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1512 bags
Product Description
SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 4000mL, (legless) REF 66640 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Reason for Recall
Potential for leaking product
Distribution Pattern
US Nationwide distribution including the states of PA, MA, IL CA.
Code Information
Lot Numbers: 66640-A2404, 66640-A4324
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0003-2020
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026