DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX II Container bag, Product Code L5B4825, NDC 0941-0409-06; b) 5000 mL AMBU-FLEX II Container bag, Product Code L5B4826, NDC 0941-0409-07; and c) 6000 mL AMBU-FLEX II Container bag, Product Code L5B9770, NDC 0941-0409-01, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.

Recall Insight

This FDA Drug action (record #D-1140-2023) was formally reported on September 6, 2023, with the manufacturer initiating the action on August 11, 2023. It is classified under Moderate severity (Class II), with a current status of Terminated. Baxter Healthcare Corporation is listed as the recalling firm, operating out of Deerfield, IL. Federal records indicate a) 44,520; b) 60,762; c) 483,912 units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. Distribution data in the federal record shows the product reached: Nationwide in the USA. 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. 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 3 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.