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U.S. Department of Health and Human Services

Class 2 Device Recall Intravascular Administration Set

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  Class 2 Device Recall Intravascular Administration Set see related information
Date Initiated by Firm April 20, 2015
Date Posted May 07, 2015
Recall Status1 Terminated 3 on November 24, 2015
Recall Number Z-1591-2015
Recall Event ID 71028
510(K)Number K964435  
Product Classification Stopcock, i.V. Set - Product Code FMG
Product 113" (287cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Smallbore Quadfuse Ext Set w/MicroClave, 4 Clamps (Blue, 2 Red, White), Rotating Luer, Non-DEHP Tubing, Item No. B33303
Product Usage:
IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
Code Information Lot No. 2992754 3004256 3007508
Recalling Firm/
Manufacturer		 ICU Medical, Inc.
951 Calle Amanecer
San Clemente CA 92673-6212
For Additional Information Contact
949-366-2183
Manufacturer Reason
for Recall		 ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.
FDA Determined
Cause 2		 Under Investigation by firm
Action An Urgent Medical Device Recall letter dated 4/17/15 will be sent to customers on 4/20/15 to inform them that ICU Medical Inc. has identified a potential connection separation issue in a small number of isolated Intravenous Administration Transfer Sets. While the separation may be visually detected, if used, this failure mode could lead to leakage. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to return completed recall response form to ICU Medical by Fax at (801) 264-1755 or email to recall@icumed.com. Customers with questions or require assistance relating to the recall are 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.
Quantity in Commerce 900 units
Distribution Nationwide in US: SC, NC, MN, CT, KY, MD, FL, VA, TN
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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