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U.S. Department of Health and Human Services

Class 1 Device Recall ICU STAT 2

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  Class 1 Device Recall ICU STAT 2 see related information
Date Initiated by Firm August 19, 2014
Date Posted September 19, 2014
Recall Status1 Terminated 3 on November 18, 2014
Recall Number Z-2619-2014
Recall Event ID 69088
510(K)Number K964435  
Product Classification Stopcock, i.V. Set - Product Code FMG
Product STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set
w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9801.

Product Usage:
IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
Code Information Lot # 2768416
Recalling Firm/
Manufacturer		 ICU Medical, Inc.
951 Calle Amanecer
San Clemente CA 92673-6212
For Additional Information Contact Robert Reese
801-264-1732
Manufacturer Reason
for Recall		 ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action ICU Medical sent an Urgent Medical Device Recall letter dated August 19, 2014 to all affected customers. The letter identified the affected product, problems identified and the actions to be taken. Customers were instructed to complete the recall response form and fax to ICU Medical at (801) 264-1755 or by email: recall@icumed.com. Customers with questions or require assistance relating to this recall were instructed to contact ICU Customer Service Monday through Friday between the hours of 8:30 AM and 4:00 PM Pacific time: 866-829-9025 and select option 8, or e-mail the following address: customerservice@icumed.com. For questions regarding this recall call 801-264-1732.
Quantity in Commerce 3750 units
Distribution Worldwide Distribution - US (nationwide) in the state of WA, OR and the country of South Africa.
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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