0.9% Sodium Chloride Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E1322, NDC 0338-6304-02; b) 500 mL AVIVA Container, product code 6E1323, NDC 0338-6304-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA

Recall Insight

This FDA Drug action (record #D-1689-2012) was formally reported on October 3, 2012, with the manufacturer initiating the action on September 21, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Baxter Healthcare Corp. is listed as the recalling firm, operating out of Round Lake, IL. Federal records indicate 897,496 containers units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP). Distribution data in the federal record shows the product reached: Nationwide and Puerto Rico. 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 5 were also issued by FDA Drug. 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 14 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.