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***''
FDA Recall Z-1078-05 · Posted 2005-08-03
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Recalling FirmArgon Medical Devices, Inc
Recall StatusTerminated
Product CodeIZI
Date Initiated2005-06-27
Date Terminated2007-04-19
Product Quantity203 syringes
Reason for Recall
The firm is recalling the product due to the potential for air aspiration or fluid leakage from a faulty syringe tip.
Firm 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.
Root Cause
Other
Distribution Pattern
TN, IL, WI, MA, VA, IN, LA, TX, CA, JAPAN, GERMANY, THE NETHERLANDS
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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