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Class 2 Device Recall 12cc Sterile syringe |
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Date Initiated by Firm |
June 27, 2005 |
Date Posted |
August 03, 2005 |
Recall Status1 |
Terminated 3 on April 19, 2007 |
Recall Number |
Z-1081-05 |
Recall Event ID |
32510 |
Product Classification |
System, X-Ray, Angiographic - Product Code IZI
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Product |
Labeling is as follows:
Product labeling:
''***Argon Medical Devices***RE-ORDER NO./REF 193248***12cc Control Syringe***ST/FR/TR/FM w/ Reservoir***This device is designed for the administraion and removal of fluids.***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***''
Carton Labeling: ''***Argon Medical Devices***12cc Control Syringe***ST/FR/TR/FM W/ Reservoir***This device is designed for the administraion and removal of fluids.***REF/REORDER NO. 193248***Quantity: 25 ea.***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***'' |
Code Information |
Reorder #: 00-193248 - Lot #: 99444008 |
Recalling Firm/ Manufacturer |
Argon Medical Devices, Inc 1445 Flat Creek Rd Athens TX 75751-5002
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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.
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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 |
34 syringes |
Distribution |
TN, IL, WI, MA, VA, IN, LA, TX, CA, JAPAN, GERMANY, THE NETHERLANDS |
Total Product Life Cycle |
TPLC Device Report
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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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