Advanta SuperSoft Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.

Recall Insight

This FDA Devices action (record #Z-2306-2013) was formally reported on October 9, 2013, with the manufacturer initiating the action on July 12, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Atrium Medical Corporation is listed as the recalling firm, operating out of Hudson, NH. The number of affected units is not disclosed in the agency filing, which is common for drug and food recalls where lot-level tracking supersedes unit counts.

The documented reason for this recall is: Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) and internationally to the following countries: American Samoa Antilles Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Canada Chile Colombia…. 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 13 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.