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U.S. Department of Health and Human Services

Class 2 Device Recall 12cc Nonsterile syringe

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  Class 2 Device Recall 12cc Nonsterile 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-1080-05
Recall Event ID 32510
Product Classification System, X-Ray, Angiographic - Product Code IZI
Product Labeling is as follows:

Product Labeling:

''***Argon Medical Devices***12cc Control Syringe***FR/TR/RM w/ Reservoir***SINGLE USE ONLY***REF/REORDER NO. 093209***This device is designed for the administraion and removal of fluids.***Quantity: 250 ea.***NON-STERILE*FURTHER PROCESSING REQUIRED***Eto (ethylene oxide) Sterilization Recommended******1445 Flat Creek Road Athens, TX 75751 800-927-4669***''

Carton Labeling:
''***Argon Medical Devices***12cc Control Syringe***FR/TR/RM w/ Reservoir***SINGLE USE ONLY***REF/REORDER NO. 093209***This device is designed for the administraion and removal of fluids.***Quantity: 250 ea***NON-STERILE*FURTHER PROCESSING REQUIRED***EtO (ethylene oxide) Sterilization Recommended***1445 Flat Creek Road Athens, TX 75751 800-927-4669***''
Code Information Reorder #: 00-093209 - Lot #: 99440951 Reorder #: 00-093209 - Lot #: 99443816 Reorder #: 00-093211 - Lot #: 99443819    
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 2752 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.
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