NAMIC Convenience Kit, UPN H749602301481, REF/Catalog No. 60230148, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Recall Insight

This FDA Devices action (record #Z-1189-2015) was formally reported on March 4, 2015, with the manufacturer initiating the action on January 9, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Navilyst Medical, Inc is listed as the recalling firm, operating out of Glens Falls, NY. Federal records indicate 2502 units units are affected.

The documented reason for this recall is: The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. Use of a Fluid Management Convenience Kit, where sterility has be… Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.. 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 11 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.