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.

Recall Insight

This FDA Devices action (record #Z-0004-2020) was formally reported on October 9, 2019, with the manufacturer initiating the action on September 21, 2018. It is classified under Moderate severity (Class II), with a current status of Ongoing. The Metrix Company is listed as the recalling firm, operating out of Dubuque, IA. Federal records indicate 141120 bags units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: Potential for leaking product Distribution data in the federal record shows the product reached: US Nationwide distribution including the states of PA, MA, IL CA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 7 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.