PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices).

Recall Insight

This FDA Devices action (record #Z-0960-2019) was formally reported on March 6, 2019, with the manufacturer initiating the action on July 3, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Abbott Vascular is listed as the recalling firm, operating out of Temecula, CA. Federal records indicate 26 units units are affected.

The documented reason for this recall is: Incorrect expiration being entered for one lot. Distribution data in the federal record shows the product reached: US Nationwide Distribution - NC and NY. 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.