Port Access Kit with MicroClave Clear Connector, Item No. B79104 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.

Recall Insight

This FDA Devices action (record #Z-2295-2014) was formally reported on August 27, 2014, with the manufacturer initiating the action on August 5, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. ICU Medical, Inc. is listed as the recalling firm, operating out of San Clemente, CA. Federal records indicate 400 units units are affected.

The documented reason for this recall is: ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and potentially product sterility. Distribution data in the federal record shows the product reached: Nationwide Distribution - USA including AL and MD.. 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 12 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.