Z-0004-2020 Class II Ongoing
FDA device recall Z-0004-2020 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: 141120 bags.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 9, 2019
- Initiation Date
- Sep 21, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 141120 bags
Product Description
SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 1500mL, REF 66616 (Canadian distribution) - 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: 66616-A2442, 66616-A2524, 66616-A2725, 66616-A2906, 66616-A2974, 66616-A3033, 66616-A3309, 66616-A3310, 66616-A3318, 66616-A3520, 66616-A3554, 66616-A3559, 66616-A3737, 66616-A3773, 66616-A3794, 66616-A3977, 66616-A4081, 66616-A4147, 66616-A4443, 66616-A4516, 66616-A5064, 66616-A5281, 66616-A5410, 66616-A5550, 66616-A5669
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0004-2020
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026