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U.S. Department of Health and Human Services

Class 2 Device Recall 6" Smallbore Ext Set

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  Class 2 Device Recall 6" Smallbore Ext Set see related information
Date Initiated by Firm March 01, 2018
Create Date August 16, 2018
Recall Status1 Terminated 3 on January 26, 2024
Recall Number Z-2816-2018
Recall Event ID 80460
510(K)Number K964435  
Product Classification Stopcock, i.V. Set - Product Code FMG
Product 6" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer.
Code Information Item Number AM6130.   a. Lot Number 3414534, UDI Number (01) 1 0887709 08771 9 (17) 220201 (30) 50 (10) 3414534, Expiration Date 02/01/2022;  b. Lot Number 3442461, UDI Number (01) 1 0887709 08771 9 (17) 220501 (30) 50 (10) 3442461, Expiration Date 05/01/2022;  b. Lot Number 3509517, UDI Number (01) 1 0887709 08771 9 (17) 220801 (30) 50 (10) 3509517, Expiration Date 08/01/2022
Recalling Firm/
Manufacturer		 ICU Medical de Mexico, S.A. de C.V.
Avenida Cuarzo 250
Ensenada
Ejido Maneadero Mexico
Manufacturer Reason
for Recall		 ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
FDA Determined
Cause 2		 Other
Action ICU Medical notified customers of the recall on about 03/01/2018 via URGENT: Medical Device Recall Notification. The notification informed customers that this was an update and expansion to previously initiated recall. Instructions included to inspect inventory for affected devices, arrange for the return of affected devices, and complete and return the Urgent Medical Device Recall Notification Response Form to recall@icumed.com.
Quantity in Commerce 300 pouches
Distribution US distribution to AZ, MA, NC, OH, TX, VA, WA. Worldwide distribution to Belgium, France, Germany.
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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