Class 1 Device Recall ChemoLock(TM) Vial Spike,

• Date Initiated by Firm: January 03, 2019
• Date Posted: February 22, 2019
• Recall Status: Completed
• Recall Number: Z-0805-2019
• Recall Event ID: 81942
• 510(K)Number: K131549
• Product Classification: Closed antineoplastic and hazardous drug reconstitution and transfer system - Product Code ONB
• Product: icumedical ChemoLock(TM) Vial Spike, 20mm, REF CL-80S; ; The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system.
• Code Information: Lot Number 3757712
• Recalling Firm/ Manufacturer: ICU Medical, Inc.; 951 Calle Amanecer; San Clemente CA 92673-6212
• For Additional Information Contact: 877-946-7747
• Manufacturer Reason for Recall: There is a potential for one lot of ChemoLock Vial Spike to contain burr particulate
• FDA Determined Cause: Vendor change control
• Action: On 01/03/2019, Stericycle, Inc. sent an " URGENT: MEDICAL DEVICE RECALL" notification of the recall to ICU Medical direct consignees of record via traceable mailing. Consignees who further distributed the product were asked to notify their customers. The notification described the product, problem and actions to be taken. The consignees were instructed to do the following: 1)Please discontinue the use and distribution of the affected product immediately. Check your inventory and quarantine all affected product at your facility. 2) Inform potential users of the product in your organization of this notification and complete the attached response form. Return the completed response form to the fax number or e-mail address on the form, even if you do not have the affected product. 3) Return affected product using the return label provided with this letter. Contact Stericycle at 1-888-871-7114 (M-F, 8am-5pm ET) if you have not received a return label or require additional labels for returning the affected product. The return labels are for single use only. Please do not reproduce. Please visit http://expertezlabel.com to request additional labels for returning affected product. To ensure proper and timely credit, follow the instructions on the return label for returning product. Upon receipt of the completed response form and return of the affected product, ICU Medical will credit you for any product returned. 4) If you have distributed the product further, immediately notify your accounts that received the product identified in the Affected Product/ Table 1 sections of this notification and ask them to contact Stericycle at 1-888-871-7114 (M-F, 8am-Spm ET) to obtain a response form. For further inquiries, including product replacement options, please contact ICU Medical using the information provided below. Global Complaint Management at 1-844-654-7780 or email to: (ProductComplaintsPP@icumed.com) To report adverse events or product complaints or
• Quantity in Commerce: 2050 units
• Distribution: US Distribution to states of: OH, FL, IA, CA, PA, IL, VA; and internationally to: AUSTRIA, CHINA (TAIWAN), IRELAND, ITALY and SINGAPORE.
• 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.

• 510(K) Database: 510(K)s with Product Code = ONB and Original Applicant = ICU MEDICAL INC