Class 2 Device Recall COOL LINE Intravascular Heat Exchange Catheter kit

• Date Initiated by Firm: August 06, 2021
• Create Date: October 06, 2021
• Recall Status: Open, Classified
• Recall Number: Z-0044-2022
• Recall Event ID: 88671
• 510(K)Number: K150046
• Product Classification: System, hypothermia, intravenous, cooling - Product Code NCX
• Product: ZOLL, REF 8700-0781-14 (CL-2295CO), COOL LINE Intravascular Heat Exchange Catheter kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, STERILE EO, Rx Only, UDI: (01)00849111075510
• Code Information: All Lots
• Recalling Firm/ Manufacturer: ZOLL Circulation, Inc.; 2000 Ringwood Ave; San Jose CA 95131-1728
• For Additional Information Contact: Sam Nanavati; 408-419-2950
• Manufacturer Reason for Recall: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
• FDA Determined Cause: Labeling design
• Action: Between the dates of August 27, 2021 and September 3, 2021, ZOLL, issued an "Urgent Medical Device Recall (Correction)" Notification to all affected US consignees via UPS. In addition to informing consignees about the labeling correction, Zoll asked consignees to take the following actions: 1. If you have any questions, please contact Doug Lam (Director of Quality and Compliance) or Sam Nanavati (VP of Quality and Regulatory Affairs) at IVTM_Recall@zoll.com. 2 Provide this notice (letter) to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. 3 Maintain a copy of the recall notification and attachment with the IFU for reference. ZOLL will provide a method to obtain the updated IFU once it is released. 4 If you experience any adverse reactions or quality problems with the use of our products (catheters), you may report adverse reactions or quality problems to the FDA s MedWatch Adverse Event Reporting program either online (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=consumer.reporting1), by regular mail or by fax (1-800-332-0178). 5 Sign and return the pre-stamped post card (enclosed) acknowledging that you have read and understood the content and requirements on this recall notice (letter) within 5 working days from receipt of this notice. 6. If you do not believe that you are the right person to implement the above-mentioned actions, please forward this letter to the right person in your organization. Actions Underway by ZOLL: 1. ZOLL will submit a revised IFU to FDA with heavy focus on providing clear instructions to the users on how to investigate/mitigate a potential catheter leak whenever a depleted saline bag is noticed by the users. 2. ZOLL will provide all affected users a method to obtain the revised IFU once it is reviewed and cleared by the FDA. 3. ZOLL is retraining all Sales staff to the revised IFU. 4. If we could be of any further assi
• Quantity in Commerce: 11 UNITS
• Distribution: Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV and the countries Australia, CANADA, CHINA, GERMANY, HUNGARY, PORTUGAL, SINGAPORE, TAIWAN, THAILAND.
• 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 = NCX and Original Applicant = Zoll Circulation, Inc.