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U.S. Department of Health and Human Services

Class 2 Device Recall 6 (15 cm) Smallbore Trifuse Ext Set w/3 Microclave" Clear, 0.2 Micron Filter, 1.2 Micron Filter, 3

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  Class 2 Device Recall 6 (15 cm) Smallbore Trifuse Ext Set w/3 Microclave" Clear, 0.2 Micron Filter, 1.2 Micron Filter, 3 see related information
Date Initiated by Firm July 01, 2020
Create Date December 01, 2020
Recall Status1 Terminated 3 on December 01, 2022
Recall Number Z-0511-2021
Recall Event ID 86075
510(K)Number K964435  
Product Classification Stopcock, i.V. Set - Product Code FMG
Product REF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 0.2 Micron Filter, 1.2 Micron Filter, 3 Clamps (Blue, Yellow, White), Rotating Luer - Product Usage: 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 catheter (which is inserted into a vein).

Directions for Use:
icumedical IV Extension Sets Clave/MicroClave/NanoClave Connectors Antimicrobial Clave/MicroClave Connectors
Spiros Closed Male Luer.
Code Information Product code : MC330209; Lot numbers:4447222, 4536285, 4572773, 4603405 Unique Device Identifier (UDI)s: (01)10887709080543(17)241101(30)50(10)4447222; (01)10887709080543(17)241201(30)50(10)4536285; (01)10887709080543(17)250101(30)50(10)4572773; (01)10887709080543(17)250101(30)50(10)4603405          
Recalling Firm/
Manufacturer		 ICU Medical, Inc.
951 Calle Amanecer
San Clemente CA 92673-6212
For Additional Information Contact Tom McCall
224-706-2670
Manufacturer Reason
for Recall		 Incorrect filter assemblies in IV administration set.
FDA Determined
Cause 2		 Component design/selection
Action On 07/01/2020, the firm sent an Urgent: Medical Device Recall" to customers via mail, by third party to inform them that the firm has become aware that there is a potential problem related to the IV administration set with incorrect filter, which may result in delay in therapy, contamination or particulate embolism. This recall affected specific lots. The firm is instructing customers to discontinue the use, distribution and quarantine the products, print the return label from http://expertezlabel.com and return the affected devices to third party contracted service and if questions, to contact ProductComplaintsPP@icumed.com or 1-844-654-7780 for adverse event or complaints and for additional assistance, to call 1-866-829-9025, option 8 or customerservice@icumed.com. .
Quantity in Commerce 1100 units
Distribution U.S. Nationwide distribution including in the states of WI, MA, CA, FL, MN, IL, NY.
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.
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