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U.S. Department of Health and Human Services

Class 2 Device Recall 168 cm (66") Appx 2.6 ml, PVC/PUR Smallbore Ext Set

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 Class 2 Device Recall 168 cm (66") Appx 2.6 ml, PVC/PUR Smallbore Ext Setsee related information
Date Initiated by FirmMay 30, 2017
Date PostedJune 26, 2017
Recall Status1 Completed
Recall NumberZ-2717-2017
Recall Event ID 77560
510(K)NumberK964435 
Product Classification Stopcock, i.V. Set - Product Code FMG
Product168 cm (66") Appx 2.6 ml, PVC/PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 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. 3297341, 3354442, 3388890. Item No. 011-AM6115
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
ActionCustomers 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 Commerce120 units
DistributionDistribution to Italy and France, and the following states in the US: AZ, OH, TX, WA.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FMG
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