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U.S. Department of Health and Human Services

Class 2 Device Recall 165 cm (65") PUR Smallbore Ext Set

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 Class 2 Device Recall 165 cm (65") PUR Smallbore Ext Setsee related information
Date Initiated by FirmMarch 01, 2018
Create DateAugust 16, 2018
Recall Status1 Terminated 3 on January 26, 2024
Recall NumberZ-2798-2018
Recall Event ID 80460
510(K)NumberK964435 
Product Classification Stopcock, i.V. Set - Product Code FMG
Product165 cm (65") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system.
Code Information Item Number 011-AM3003. Lot Number 3297342, UDI Number (01) 1 0840619 09275 1 (17) 210700 (30) 50 (10) 3597342, Expiration Date 07/01/2021.
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
ActionICU 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 Commerce50 pouches
DistributionUS distribution to AZ, MA, NC, OH, TX, VA, WA. Worldwide distribution to Belgium, France, Germany.
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.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FMG
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