Recalls / —
—#40218
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***''
- FDA product code
- IZI — System, X-Ray, Angiographic
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K911732
- Affected lot / code info
- Reorder #: 00-193205 - Lot # 99445447 Reorder #: 00-193205 - Lot # 99445446
Why it was recalled
The firm is recalling the product due to the potential for air aspiration or fluid leakage from a faulty syringe tip.
Root cause (FDA determination)
Other
Action the firm took
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.
Recalling firm
- Firm
- Argon Medical Devices, Inc
- Address
- 1445 Flat Creek Rd, Athens, Texas 75751-5002
Distribution
- Distribution pattern
- TN, IL, WI, MA, VA, IN, LA, TX, CA, JAPAN, GERMANY, THE NETHERLANDS
Timeline
- Recall initiated
- 2005-06-27
- Posted by FDA
- 2005-08-03
- Terminated
- 2007-04-19
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #40218. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.