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U.S. Department of Health and Human Services

Class 2 Device Recall 10 cc Sterile Custom Manifold Kit

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 Class 2 Device Recall 10 cc Sterile Custom Manifold Kitsee related information
Date Initiated by FirmJune 27, 2005
Date PostedAugust 03, 2005
Recall Status1 Terminated 3 on April 19, 2007
Recall NumberZ-1077-05
Recall Event ID 32510
510(K)NumberK911732 
Product Classification System, X-Ray, Angiographic - Product Code IZI
ProductLabeling is as follows: Product Labeling: ''***Argon Medical Devices***CUSTOM MANIFOLD KIT***REF/REORDER NO. 194902A***CONTENTS: 1 3-Port Manifold, 500 PSI***1 ASY CDX3 Transducer***1 Stopcock Assy 1-Way w/ MLL***1 72'' Vented Spike Line***1 10cc Control Syringe***1 M/F L/L PVC Line*** 1 Stopcock Assy 4-way w/ MLL***1 Rotating Adapter, M/M***1 35/150/FC/PTFE/3J/XTB Guidewire***1 Angio Flushing Set***1 Zero Port Plug, Serrated***1 Monitor Line Labels***STERILE EO***STERILIZED BY EtO***DISPOSABLE***SINGLE-USE***DO NOT RESTERILIZE***Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751 800-927-4669***'' Carton Labeling: ''***Argon Medical Devices***CUSTOM MANIFOLD KIT***REF/REORDER NO. 194902A***Quantity: 10 ea***DISPOSABLE***SINGLE-USE***DO NOT RESTERILIZE***STERILE EO***STERILIZED BY EtO***Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751 800-927-4669***''
Code Information Reorder #: 00-194902A - Lot #: 99444872 
Recalling Firm/
Manufacturer		 Argon Medical Devices, Inc
1445 Flat Creek Rd
Athens TX 75751-5002
Manufacturer Reason
for Recall		The firm is recalling the product due to the potential for air aspiration or fluid leakage from a faulty syringe tip.
FDA Determined
Cause 2		Other
ActionThe firm plans to distribute recall letters to all customers indicated on the customer list. TELEPHONE 6/27/2005. All products will be returned to Argon and disposed.
Quantity in Commerce160 kits
DistributionTN, IL, WI, MA, VA, IN, LA, TX, CA, JAPAN, GERMANY, THE NETHERLANDS
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 = IZI
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