STERILE CAP CHANGE KIT DYNDC1946B

Recall Insight

This FDA Devices action (record #Z-0086-2020) was formally reported on October 16, 2019, with the manufacturer initiating the action on April 24, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Centurion Medical Products Corporation is listed as the recalling firm, operating out of Williamston, MI. Federal records indicate 181965 total units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disc… Distribution data in the federal record shows the product reached: Nationwide domestic distribution.. 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.