Class 2 Device Recall Tearaway Introducer Kit

• Date Initiated by Firm: May 08, 2023
• Date Posted: June 15, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1968-2023
• Recall Event ID: 92322
• 510(K)Number: K153533
• Product Classification: Introducer, catheter - Product Code DYB
• Product: Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16
• Code Information: REF/UDI-DI/LOT (Expiration): KIT-010-12/00841268105195/S23104607(2/05/2027), S22356870(1/11/2027); KIT-010-17/00841268105249/S23083725(2/05/2027), S22231321(9/08/2026), S22328872(1/18/2027); KIT-900-16/S22308637(1/04/2027)
• FEI Number: 3000718472
• Recalling Firm/ Manufacturer: Galt Medical Corporation; 2220 Merritt Dr; Garland TX 75041-6137
• Manufacturer Reason for Recall: 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, and can require the use of a replacement device.
• FDA Determined Cause: Process design
• Action: On 5/5/23, recall notices were sent to customers who were asked to do the following: 1) Identify and segregate the affected lot(s) that are in your possession as well as those in the possession of your end-users. 2) Complete and return the field correction reply form to quality@galtmedical.com 2) Return affected product to the recalling firm. Customers with questions can email: dderrick@galtmedical.com
• Quantity in Commerce: 490
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = DYB