Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, Inc., Arvada, CO.

Recall Insight

This FDA Devices action (record #Z-0664-2018) was formally reported on February 28, 2018, with the manufacturer initiating the action on December 19, 2017. It is classified under Low severity (Class III), with a current status of Terminated. LivaNova USA is listed as the recalling firm, operating out of Arvada, CO. Federal records indicate 16 units (6 from lot 1717800062 and 10 units from lot 1720800071 units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: The product is labeled with the incorrect expiration date. Distribution data in the federal record shows the product reached: Distribution was made to one consignee in LA.. 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 and NHTSA 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 8 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.