Class 2 Device Recall WOLFPAK Self Safe Safety IV Catheter

• Date Initiated by Firm: June 21, 2021
• Create Date: August 16, 2021
• Recall Status: Open, Classified
• Recall Number: Z-2305-2021
• Recall Event ID: 88234
• 510(K)Number: K200373
• Product Classification: Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
• Product: WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W
• Code Information: a) REF PIVD2010W, Lot 1100256 b) REF PIV2210W, Lot 1100316 c) REF PIV2475W, Lot 1200084
• Recalling Firm/ Manufacturer: Delta Med SpA; Via Guido Rossa 20; Viadana Italy
• Manufacturer Reason for Recall: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
• FDA Determined Cause: Process control
• Action: The firm disseminated the notices on 06/21/2021 by email. The firm is requesting destruction of the affected devices at the consignee.
• Quantity in Commerce: 40,000 units
• Distribution: US Nationwide distribution in the states of FL and MN.
• 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 = FOZ