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U.S. Department of Health and Human Services

Class 2 Device Recall 6.5" (17 cm) Appx. 0.57 ml, Trifuse Ext Set w/3 MicroClave Clear, NanoClave TConnector

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  Class 2 Device Recall 6.5" (17 cm) Appx. 0.57 ml, Trifuse Ext Set w/3 MicroClave Clear, NanoClave TConnector see related information
Date Initiated by Firm February 05, 2018
Create Date April 10, 2018
Recall Status1 Terminated 3 on September 17, 2019
Recall Number Z-1343-2018
Recall Event ID 79077
510(K)Number K964435  
Product Classification Stopcock, i.V. Set - Product Code FMG
Product 6.5" (17 cm) Appx. 0.57 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, NanoClave¿ T-Connector, 4 Clamps, Rotating Luer, Item A1254, 50 pouches per case, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA.

The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
Code Information Lot number 3533699, UDI (01) 0 0887709 09040 8 (17) 220901 (30) 01 (10) 3533699, and lot number 3549590, UDI  (01) 0 0887709 09040 8 (17) 221001 (30) 01 (10) 3549590.  
Recalling Firm/
ICU Medical, Inc.
951 Calle Amanecer
San Clemente CA 92673-6212
Manufacturer Reason
for Recall
The infusion sets were manufactured with an incorrect spin collar.
FDA Determined
Cause 2
Process control
Action The firm, ICU Medical Inc., sent an "URGENT: Medical Device Recall Notification" letter dated 2/5/2018 to its customers via UPS on 2/5/2018 in the U.S. The letter described the product, problem and actions to be taken. The customers were instructed to: inspect your inventory for specific product and lot numbers; quarantine all affected devices; complete and return the Recall Response Form as applicable (even if you have no affected devices) via Fax to: 1-866-899-7474 or email to: ICUMedical2805@stericycle.com; if you have distributed the product further, notify your accounts that received the product and ask them to contact Stericycle at 1-866-629-6182 (M-F, 8am-5pm ET) to receive a Response Form. Return affected product to Stericycle using labels provided, if you have not received a return label or reply form or require additional assistance, please contact Stericycle at 1-866-629-6182 (M-F, 8am-5pm) the return labels are for single use only. For additional labels visit http://expertezlabel.com. For further inquiries, please contact ICU Medical Inc. for Global Complaint Management at ProductComplaintsPP@icumed.com or ICU Customer Service at 1-866-829-9025, option 2 (M-F, 8:30am-4pm PT).
Quantity in Commerce 550 pouches
Distribution Worldwide Distribution: US (nationwide) to state in AZ, CA, CO, FL, SC, and TX; and countries of: Canada and Japan.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FMG and Original Applicant = ICU MEDICAL, INC.