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U.S. Department of Health and Human Services

Class 2 Device Recall Cath Lab Kit W/3Port "ON" Manifold

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 Class 2 Device Recall Cath Lab Kit W/3Port "ON" Manifoldsee related information
Date Initiated by FirmJune 11, 2008
Date PostedSeptember 16, 2008
Recall Status1 Terminated 3 on April 13, 2010
Recall NumberZ-2208-2008
Recall Event ID 48681
510(K)NumberK060231 
Product Classification I.V. Set Stopcock - Product Code FMG
ProductICU Medical, Inc. Cath Lab Kit W/3Port "ON" Manifold, Waste Bag, Syringe & TP4; Item Number: AG7843 Indicated for fluid flow directional control and for providing access port(s) for administration of solutions.
Code Information Lot Numbers: 44-504-R5, 558884, 570634, and 603566
Recalling Firm/
Manufacturer		 ICU Medical, Inc.
951 Calle Amanecer
San Clemente CA 92673-6212
For Additional Information ContactShirley Hyink
801-264-1422
Manufacturer Reason
for Recall		Improper orientation of the stopcock handle questions whether there is an adequate gas path to assure sterility, which presents a possible compromise of sterility.
FDA Determined
Cause 2		Process change control
ActionEvery customer both direct and distributors who have purchased the affected lots were mailed a Product Recall Letter with attached fax-back Product Inventory Summary attachment on 06/11/2008 via fax and followed by UPS overnight delivery. The Product Recall Letter informed the customers of the reason for the recall and instructed them to complete and return the attached Product Inventory Summary. Instructions were also given for returning product in their inventory to ICU.
Quantity in Commerce100
DistributionNationwide Distribution
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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