Class 1 Device Recall icumedical Oncology Kit

• Date Initiated by Firm: February 21, 2019
• Create Date: April 15, 2019
• Recall Status: Open, Classified
• Recall Number: Z-1095-2019
• Recall Event ID: 82291
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: icumedical Oncology Kit w/12" (30cm) Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented Vial Spike, 20mm; ChemoClave Vented Vial Spike, 13mm; Spiros wRed Cap, REF 3944. Used in IV administration sets.; ; The ChemoCLAVE Cytotoxic Medication Preparation and Delivery System consists of 6 previously cleared components (CLAVE, Spikes, SPIROS, GENIE, Vial Access, and Admin Sets) that can be combined into various configurations intended for use in the preparation and patient administration of cytotoxic medications.
• Code Information: Lot Numbers: 3846116, 3855565
• Recalling Firm/ Manufacturer: ICU Medical, Inc.; 951 Calle Amanecer; San Clemente CA 92673-6212
• For Additional Information Contact: Tom McCall; 949-366-4368
• Manufacturer Reason for Recall: There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device.
• FDA Determined Cause: Vendor change control
• Action: The firm, Icumedical, initiated the recall by "URGENT: MEDICAL DEVICE RECALL" letter on 02/21/2019 to its customers. The letter described the product, problem and actions to be taken. The customers 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 via fax to: 1-855-497-9856 or email to: ICUMedical6834@stericycle.com, 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. 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-5pm ET) to obtain a response form. UPDATED INFORMATION: On 03 January 2019, ICU Medical, Inc. issued an Urgent Medical Device Recall letter informing customers of a recall of one lot (3757712) of the ChemoLock" Vial Spike, 20mm (CL-80S). As a result of continued evaluation, ICU Medical is expanding the scope of the previously distributed Urgent Medical Device Recall to include certain lots of ChemoLock" and ChemoClave¿ Vial Spikes that may also be affected by this issue. All product lots identified in this communication are impacted by this recall. If you have any questions, please contact Customer Care at 1- 877-946-7747 General inquires /Product replacement options.
• Quantity in Commerce: 300 devices
• Distribution: Worldwide distribution: US nationwide and countries of: Canada, France, 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.
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.