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U.S. Department of Health and Human Services

Class 2 Device Recall Onocology Kit

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  Class 2 Device Recall Onocology Kit see related information
Date Initiated by Firm March 16, 2021
Create Date May 13, 2021
Recall Status1 Open3, Classified
Recall Number Z-1573-2021
Recall Event ID 87703
510(K)Number K131549  
Product Classification Closed antineoplastic and hazardous drug reconstitution and transfer system - Product Code ONB
Product REF CL3946 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).
Code Information REF: CL3946   UDI: (01) 1 0887709 08029 1 (17) 260101 (30) 50 (10) 5142959   Lot Number: 5142959   
Recalling Firm/
ICU Medical, Inc.
951 Calle Amanecer
San Clemente CA 92673-6212
Manufacturer Reason
for Recall
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
FDA Determined
Cause 2
Component design/selection
Action On 03/16/2021, the firm sent an "URGENT: MEDICAL DEVICE RECALL " Letter via Stericycle, Inc. informing customers that it has identified the potential for certain lots of Spiros to exhibit small amounts of leaks due to a molding defect. Customer are instructed to: 1) Discontinue the use and distribution of the affected product immediately. Check their inventory and quarantine all affected product at their facility. 2) Inform potential users of the product in their 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 the customer does not have the affected product. 3) The Recalling Firm has some lots of unaffected product available today and is actively increasing the amount of available inventory. Please contact customer service for product availability. 4) Return affected product using the return label provided with this letter. Contact Stericycle at 1-866-300-2207 (MF, 8am-5pm ET) if customers have not received a return label or require additional labels for returning the affected product. The return labels are for single use only. Do not reproduce. Customers can 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, the Recalling Firm will credit customers for any product returned. Customers will only receive credit for product that are returned. NOTE: Credits for product purchased through distributor will be credited by the distributor. 5) If customers have distributed the product further, immediately notify those accounts that received the product identified in the Affected Product / Table 1 sections of this notification and ask them to contact Stericycle at 1-866-300-2207 (M-F, 8am-5pm ET) to obtain a response form. For
Distribution Worldwide distribution - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA and WA. The countries of Belgium, Canada, France, Italy, South Africa, Spain, United Kingdom.
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 and Original Applicant = ICU MEDICAL INC