Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16

Recall Insight

This FDA Devices action (record #Z-1968-2023) was formally reported on June 21, 2023, with the manufacturer initiating the action on May 8, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Galt Medical Corporation is listed as the recalling firm, operating out of Garland, TX. Federal records indicate 490 units are affected.

The documented reason for this recall is: Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer connection portion of the dilator hub that cracks or dislodges during use, which renders the dilator component unusable, an… Distribution data in the federal record shows the product reached: Worldwide - US Nationwide distribution in the states of PA, UT, FL, PA, OH, GA, MA, NV, CA, NY, NJ and the countries of UK, AU, TR, FR, CH, NO.. 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 3 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.