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U.S. Department of Health and Human Services

Class 2 Device Recall 18 cm (7") PUR Smallbore Ext Set

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  Class 2 Device Recall 18 cm (7") PUR Smallbore Ext Set see related information
Date Initiated by Firm May 30, 2017
Date Posted June 26, 2017
Recall Status1 Completed
Recall Number Z-2716-2017
Recall Event ID 77560
510(K)Number K964435  
Product Classification Stopcock, i.V. Set - Product Code FMG
Product 18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿, Rotating Luer.

Product Usage:
The device is a single use, sterile, non-pyrogenic device which 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 Lot No. 3172948, 3192947, 3224228, 3246765, 3260270. Item No. 011-AM6111
Recalling Firm/
Manufacturer		 ICU Medical, Inc.
951 Calle Amanecer
San Clemente CA 92673-6212
For Additional Information Contact
866-829-9025
Manufacturer Reason
for Recall		 The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Customers were notified via letter on approximately 05/30/2017 and were instructed to examine their inventory, quarantine affected products, complete and return the response form, and return to ICU Medical. If there are any questions or assistance needed, customers can call ICU Customer Service Monday through Friday between 8:30 AM and 4:00 PM Pacific time: 866-829-9025. Or they can email: Productreturns@icumed.com.
Quantity in Commerce 304 units
Distribution Distribution to Italy and France, and the following states in the US: AZ, OH, TX, WA.
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.
510(K) Database 510(K)s with Product Code = FMG and Original Applicant = ICU MEDICAL, INC.
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