Class 2 Device Recall AngioDynamics SafeSheath ULTRALITE

• Date Initiated by Firm: March 10, 2021
• Create Date: April 01, 2021
• Recall Status: Terminated on August 08, 2023
• Recall Number: Z-1329-2021
• Recall Event ID: 87562
• Product Classification: Introducer, catheter - Product Code DYB
• Product: AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters.
• Code Information: GUDID: 25051684026298; Lot Number DP-11759
• FEI Number: 1035166
• Recalling Firm/ Manufacturer: Oscor, Inc.; 3816 Desoto Blvd; Palm Harbor FL 34683-1618
• For Additional Information Contact: Bethania Tavarez; 727-937-2511 Ext. 133
• Manufacturer Reason for Recall: Potential for open seal on sterile product
• FDA Determined Cause: Under Investigation by firm
• Action: The firm notified their sole consignee of the recall by letter on 03/23/2021 as a written follow-up communication held on 03/10/2021 which requested the return of the recalled product.
• Quantity in Commerce: 500 devices
• Distribution: US Nationwide distribution in the state of New York.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.