Class 2 Device Recall ChemoLock Vial Adapter

• Date Initiated by Firm: November 06, 2024
• Date Posted: December 09, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0652-2025
• Recall Event ID: 95649
• 510(K)Number: K131549
• Product Classification: Closed antineoplastic and hazardous drug reconstitution and transfer system - Product Code ONB
• Product: ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmental contaminants. The Chemolock is needle free and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.
• Code Information: Model/Catalog Number: CL-80 UDI code: (01)10887709057125(17)290401(30)50(10)13959938 Lot Number: 13959938
• Recalling Firm/ Manufacturer: ICU Medical, Inc.; 951 Calle Amanecer; San Clemente CA 92673-6212
• For Additional Information Contact: Mrs. Mary J. Ferreira; 845-907-1429
• Manufacturer Reason for Recall: Due to finished goods incorrectly packaged and labeled.
• FDA Determined Cause: Packaging process control
• Action: On 11/06/2024, the firm send an "URGENT Medical Device Correction" Letter via third party (Sedgwick, Inc.) to customers informing them that product was incorrectly packaged and labeled. Product CL-80 package incorrectly contained product code CL-80S. The CL-80 is a used with a 20 mm or a 28 mm vial where as CL-80S is only use for a 20 mm vial. The issue is using the incorrect adapter may result in leakages. Actions to be taken by the Customer: Discontinue use mislabeled lot 13953938 of CL-80 and discard remaining product from this specific lot. 1. Check all inventory locations within your institution for the affected product listed in the notification and discontinue use. Quarantine and destroy all affected products following your institution s process for destruction. If destroying is not immediately possible at your facility, then the product should be quarantined until disposal. 2. Share this notification with all potential users of the device to ensure they are aware of this notification. If the devices are used at another location, please ensure this communication is delivered there./// 3. Complete and return the attached Customer Response Form to XXXX@sedgwick.com within 10 days of receipt to acknowledge your understanding of this notification./ / 4. DISTRIBUTORS: If you have distributed affected products to your customers, please immediately forward this notice to them. Request that they complete the response form and return it to XXXX@sedgwick.com. For questions/assistance, contact: Global Complaint Management 1-844-654-7780 (M-F, 8:00am 5:00pm CT) or ProductComplaintsPP@icumed.com To report adverse events or product complaints Customer Service 1-866-829-9025, option 8 or customerservice@icumed.com (M-F, 8:00 am 6:00 pm CT) Additional information or to request a credit. Field Action Processing 1-888-843-0245 xxx@sedgwick.com Questions about this communication
• Quantity in Commerce: 6000 units
• Distribution: Worldwide - U.S. Nationwide distribution in the state of IL and the country of Canada.
• 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 = ONB