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U.S. Department of Health and Human Services

Class 2 Device Recall 10cc Control Sterile Syringe

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  Class 2 Device Recall 10cc Control Sterile Syringe see related information
Date Initiated by Firm June 27, 2005
Date Posted August 03, 2005
Recall Status1 Terminated 3 on April 19, 2007
Recall Number Z-1078-05
Recall Event ID 32510
510(K)Number K911732  
Product Classification System, X-Ray, Angiographic - Product Code IZI
Product Product consists of a syringe used to inject fluids during an angiographic procedure for fluoroscopic imaging. Labeling is as follows:

Product Label
''***Argon Medical Device***REORDER NO./REF 193205***10cc Control Syringe FR/TR/FM w/ Reservoir***This device is designed for the administration and removal of fluids***DISPOSABLE***SINGLE USE ONLY***DO NOT RESTERILIZE***STERILE***EO***STERILIZED BY EtO***Sterile Unless Opened or Damaged***Argon Medical Devices, Inc. 1445 FLAT CREEK ROAD - ATHENS, TX 75751***800-927-4669***''

Carton Label
''***Argon Medical Device***10cc Control Syringe FR/TR/FM w/ Reservoir***This device is designed for the administration and removal of fluids***REF/REORDER NO. 193205***Quantity: 25ea***STERILE***EO***STERILIZED BY EtO***DISPOSABLE***SINGLE USE ONLY***DO NOT RESTERILIZE***Sterile Unless Opened or Damaged***Argon Medical Devices, Inc. 1445 FLAT CREEK ROAD - ATHENS, TX 75751***800-927-4669***''
Code Information Reorder #: 00-193205 - Lot # 99445447 Reorder #: 00-193205 - Lot # 99445446 
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
Action The 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 Commerce 203 syringes
Distribution TN, IL, WI, MA, VA, IN, LA, TX, CA, JAPAN, GERMANY, THE NETHERLANDS
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 = IZI and Original Applicant = ADVANCE MEDICAL DESIGNS, INC.
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